A study of acupuncturing “Chou’s Tiaoshen” acupoints on short-term insomnia patients: study protocol for a randomized controlled trial

A study of acupuncturing “Chou’s Tiaoshen” acupoints on short-term insomnia patients: study protocol for a randomized controlled trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol A study of acupuncturing “Chou’s Tiaoshen” acupoints on short-term insomnia patients: study protocol for a randomized controlled trial ZiYi Wong, Qiuyang Hong, Yeqing He, XiaoYu Yan, Qian Liu, Mingyang Cao, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4182329/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: The incidence of short-term insomnia is high. Timely intervention of short-term insomnia has important significance to prevent it from developing into chronic insomnia which can lead to a heavy health burden. At present, the treatment of short-term insomnia is limited. Acupuncture is an effective and mature treatment for insomnia with a long history in China and is increasingly recognized internationally. However, there are few studies on short-term insomnia and no clinical studies on acupuncture treatment of short-term insomnia reported. Methods: Our team intends to conduct a randomized controlled trial to compare the "Chou’s Tiaoshen" acupuncture method with estazolam to explore the effectiveness of acupuncture in the treatment of short-term insomnia. A total of 88 eligible patients with short-term insomnia will be randomized in a ratio of 1:1 to the acupuncture group ("Chou’s Tiaoshen" acupoints) and estazolam group. The primary outcome measure is Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures are Polysomnography (PSG), heart rate variability (HRV), serum cortisol, Ford Insomnia Response to Stress Test (FIRST), daytime functional scale, Traditional Chinese Medicine（TCM） symptom scoring Scale. Clinical assessments will be performed both at baseline and after treatment. Discussion: This study aims to explore the therapeutic effect of acupuncture in the treatment of short-term insomnia. Furthermore, more and more studies have suggested that compared with chronic insomnia, short-term insomnia is more related to hyperarousal. We will explore the possible mechanism of acupuncture in the treatment of short-term insomnia from the perspective of hyperarousal mechanism by testing heart rate variability, serum cortisol and FIRST. Ethics and trial registration: This protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine (Beijing TCM Hospital), the approval number is 2023BL02-103-02. It’s also been registered on ClinicalTrials.gov (URL: https://clinicaltrials.gov/study/NCT06212934 ). Short-term insomnia Acupuncture hyperarousal Figures Figure 1 BACKGROUND According to International Classification of Sleep Disorders Third Edition (ICSD-3) diagnostic criteria , short-term insomnia is defined as difficulty in falling asleep or staying asleep, as well as daytime dysfunction in the presence of adequate sleep opportunities, and these symptoms occur for less than 3 months. The annual prevalence of short-term insomnia has been found to be 27%, with 19% of these patients continuing to have poor sleep and developing into chronic insomnia . Another study has shown that 1 in 5 patients with short-term insomnia will progress to chronic insomnia . An article titled "Insomnia" published in the Lancet in 2022 states that the best time for medical management of insomnia is 2 or more weeks after the onset of insomnia . Timely intervention of short-term insomnia is of great significance in preventing it from developing into chronic insomnia and decreasing the heavy health burden. Insomnia is associated with the negative consequences of many diseases, such as cardiovascular diseases, cancer, hypertension, and diabetes . It is also associated with higher rates of workplace injuries and traffic accidents , . The direct and indirect losses it causes each year exceed 100 billion dollars annually, much higher than other mental illnesses , . The control of short-term insomnia has been has been paid more and more attention by scholars, but the treatment of short-term insomnia has not made a breakthrough due to the lack of patient's understanding of short-term insomnia as well as the adverse reaction of drug. At present, most scholars believe that short-term insomnia is mainly treated with non-drug therapy, such as cognitive behavioral therapy for insomnia(CBT-I), which intends to improve sleep by changing the patient's poor sleep beliefs and behaviors. However, there is a lack of professional practitioners and each treatment takes a lot of time, CBT-I has not been effectively carried out in clinical practice. Benzodiazepines such as estazolam are used only when insomnia produces severe and incurable personal stress, but the adverse reaction of applying the above drugs will unavoidably occur in varying degrees . Therefore, in-depth research on short-term insomnia, searching for more effective treatments with fewer side effects, and exploring the acting factors of efficacy are extremely important for the management and prevention of short-term insomnia. Acupuncture, the most original and advantageous non-drug therapy in China, is convenient, inexpensive, effective, and has few side effects, and is now being used more and more in the international arena. A recent review shows that acupuncture can improves both subjective sleep quality and objective sleep processes, it also suggested that the most commonly adopted acupoints for treating primary insomnia are Shenmen (HT7), Baihui (GV20), and Sanyinjiao (SP6). “Chou’s Tiaoshen” acupoints(including Baihui (GV-20), Shenting (GV-24), Benshen(BG-13), Sishencong (EX-HN1), Neiguan(PC-6), Shenmen (HT-7), and Sanyinjiao (SP-6)), derived from the experience of a national famous veteran traditional Chinese medicine practitioner of our department, has achieved good efficacy in the preliminary studies related to insomnia, which can improve both the nighttime sleep quality of the patients and their daytime awakening state , . The etiology of short-term insomnia is unclear and cannot be attributed to a single source, but involves multiple environmental, genetic, psychological, and behavioral factors, but there is a developing consensus that short-term insomnia is a “hyperarousal” disorder . Bonnet first proposed the mechanism hypothesis of hyperarousal in 1997 . Hyperarousal refer to overreaction to sleep stress stimuli. Hyperarousal can be manifested in faster electrical brain frequency reflected by electroencephalogram, increased functional activity of the autonomic nervous system, over activity of the hypothalamic-pituitary-adrenal axis, and the release of inflammatory factors. More and more studies have shown that high sleep reactivity is an important cause of acute insomnia . Compared to participants with low sleep reactivity, participants with high sleep reactivity were 76% more likely to develop acute insomnia within a year . People with highly reactive poor sleep are two to three times more likely to develop chronic insomnia than people with non-reactive poor sleep . FIRST (Ford Insomnia Response to Stress Test) is a kind of self- reporting tools to assess sleep reaction . Heart Rate Variability (HRV) can respond to the enhanced symptomatic activity of sleep, which is related to the hyperarousal state of the central nervous system of patients with insomnia . Serum cortisol can reflect the functional status of the Hypothalamic-Pituitary-Adrenal axis (HPA axis), a pivot of the body's response to stress including insomnia, and participates in the regulation of sleep homeostasis, and also plays an important role in the promotion of arousal and the regulation of sleep .It’s also shown that hyper reactive sleepers have decreased REM sleep and increased nighttime wakefulness under stress (especially during REM sleep) . In summary, there are few studies on short-term insomnia, and effective and timely intervention is often not available, which brings serious disease burden. The mechanism is still not clear, and recent studies suggest that short-term insomnia is associated with hyperarousal. In this study, we designed a randomized controlled trial comparing acupuncturing “Chou’s Tiaoshen” acupoints on short-term insomnia patients with estazolam. We chose Pittsburgh Sleep Quality Index (PSQI) as the primary outcome measure to explore the effect of acupuncture on short-term insomnia. We also focus on the mechanism of hyperarousal in short-term insomnia by testing FIRST, serum cortisol, HRV and polysomnography (PSG) to explore the mechanism of acupuncture on short-term insomnia. METHODS Trail design This is a multi-center, randomized controlled, blind evaluated and non-inferiority study, with estazolam as a control, aiming to explore whether “Chou’s Tiaoshen” acupoints is non-inferior to estazolam and the possible mechanism of acupuncture for short-term insomnia. A total of 88 participants will be randomly assigned to two different groups. Participants will receive acupuncturing “Chou’s Tiaoshen” acupoints in the acupuncture group five times a week and last for 2 weeks. While participants in the estazolam group will take estazolam before bedtime in the day and the treatment will also be given for 2 weeks. Polysomnography, heart rate variability, cortisol and related scales will be measured before and after treatment to detect the changes in symptoms and signs. The time schedule can be seen in figure 1. This protocol is reported based on the SPIRIT guidelines[i] (the SPIRIT checklist of this protocol is available in the supplementary material). Participants and recruitment Participants with short-term insomnia will be recruited from the outpatient clinic at two different wards of Beijing TCM Hospital ( Dongcheng ward and Shunyi ward) from 2024.3 to 2025.3. Sample size estimation According to the existing literature[ii], estazolam treatment for insomnia can make PSQI score decrease 5.51 ± 3.37 than before. According to our previous work[iii], acupuncturing “Chou’s Tiaoshen” acupoints for insomnia can make PSQI score decreased 5.17 ± 3.55 than before. Therefore, the non-inferiority test was used in this study, and the non-inferiority threshold “Δ” was set as “-2”. The test level is set as α =0.025 (one side), the test efficiency is 1- β =0.80, and the sample size calculation formula is based on the comparing of means of the two samples. It was calculated that a minimum of 35 patients will be required in each group. Considering lost follow-up, excluded and detached cases (controlled below 20%), it requires the sample size of at least 44 cases in each group and the total sample size of at least 88 cases. Inclusion criteria 1. Meet the diagnostic criteria for short-term insomnia according to the Diagnostic and Statistical Manual of Mental Disorders Text Revision, 5 th edition (DSM-V) and Chinese Adult Insomnia Diagnosis and Treatment Guide 2017[iv]: A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms: 1)Difficulty initiating sleep. 2). Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. 3) Early-morning awakening with inability to return to sleep. 4) The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. The duration of the sleep difficulty is 1 week to 3 months. 2. Aged between 18 and 70 years old. Male or female. 3. Patients who agreed to participant in this trial and assigned the informed consent (Available in the related files). Exclusion criteria 1. People with other DSM-V Axis I, Axis II mental disorders or substance abuse/dependence. 2. Patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, hypertension, digestive system, hematopoietic system, liver, kidney, or severe anxiety and depression. 3. Caused by alcohol or drugs. 4. Pregnant or lactating women. 5. Easy to combine infection and bleeding. 6. Patients who have used psychotropic drugs, such as antidepressants, mania drugs or other drugs used to treat psychosis, in the last month, and patients who have taken sleeping pills in the last 1 month. 7. Those who cannot cooperate with treatment. Elimination criteria Take other anti-insomnia drugs or other treatments during the observation period. Shedding criteria 1. Quit due to poor efficacy or sever adverse effects; 2. Patients who were lost to follow-up. Randomization and allocation concealment The included participants were divided into acupuncture group or estazolam group according to the randomization principle. The group randomization method generated random number table using SPSS 20.0 software, corresponding group code into envelopes and sealed (unrecoverable after unpacking). The allocation ratio of the two groups is 1:1. Random envelopes are made by special personnel to achieve covert grouping. Qualified patients were enrolled according to the randomized protocol. The number of the randomized envelope is the serial number of the patients enrolled. Select in the order of small to large, open the randomized envelope, and operate according to the prompts in the randomized envelope. We will keep the concealment of the randomized method during the trials. Blinding It is difficult to blind the researchers and participants in this study, we only perform blinded evaluation. Provisions for concomitant medication or treatment Allowed concomitant medication / treatment: In the course of the trial, the medication of the Pre-existing disease, such as coronary heart disease, diabetes mellitus and hyperlipidemia, can be remain unchanged, and the combined medication of the subjects should be recorded in detail. Concomitant medication / treatment prohibited: other anti-insomnia drugs or other insomnia treatment. Acupuncture group “Chou’s Tiaoshen” acupoints include Baihui (GV-20), Shenting (GV-24), Benshen(BG-13), Sishencong (EX-HN1), Neiguan(PC-6), Shenmen (HT-7), and Sanyinjiao (SP-6). Using stainless steel needles (0.18×40 mm, HuaTuo, China). Then some other points like, Taichong (LR3), Daling(PC-7), Danzhong(CV-17), Taixi (KI-3), Qihai (CV-6), and Qiuxu(GB-40) are chosen based on participant’s unique pattern. Operation: Patients in supine position. Baihui (GV-20), Shenting (GV-24), Benshen(BG-13), and Sishencong (EX-HN1) are punctured at a depth of 5-10mm obliquely. Neiguan(PC-6), Sanyinjiao (SP-6), and Shenmen (HT-7) are inserted 10-15mm perpendicularly. Until feeling tactile sensation then manually manipulated by rotation methods to produce a characteristic sensation known is known as "De Qi". Technique: Mild reinforcing and attenuating, retaining the needle for 30minutes. The treatment will be given once a day and 5 times a week in weekdays, the course will last 2 weeks. Estazolam group Participants will take estazolam tablets (1 mg/day) 30min prior to bedtime. The course will last 2 weeks. Primary outcome measure Sleep quality will be measured using the scale of Pittsburgh Sleep Quality Index (PSQI) at baseline, day 14 and day 28. PSQI is a self-rated questionnaire which assesses sleep quality and disturbances. Eighteen individual items generate seven “component” scores: subjective sleep quality (SQ), sleep-onset latency (SOL), total sleep time (TST), habitual sleep efficiency (SE), sleep disturbances ( Dyssomnia), use of sleeping medication, and daytime dysfunction (DD).The cumulative component score is the PSQI total score ranging from 0 to 21, higher scores indicates worse sleep quality. Secondary outcome measures Objectivity sleep quality and related sleep events are measured by polysomniography (PSG) at baseline and day 14. PSG is a classic instrument for detecting sleep conditions. The following data can be obtained by PSG monitoring: total sleep time, sleep latency, The percentage of time spent in each sleep stage. Previous studies have shown differences between subjective and objective sleep. PSG is of great value for the degree and differential diagnosis of insomnia. Heart rate variability (HRV) is used to assess autonomic tone at baseline and day 14. The degree and regularity of heart rate changes can be reflected by measuring the variability of continuous normal R-R interphase changes by dynamic electrocardiogram, so as to judge its impact on cardiovascular activities, which can reflect the activity of autonomic nervous system and quantitatively evaluate the balance of sympathetic and vagal nerve tension. Serum cortisol is used to assess autonomic tone at baseline and day 14. Cortisol changes in the body in a circadian rhythm and we will test serum cortisol at 8 am. Serum cortisol is elevated during stress, which can reflect excessive arousal. The serum samples are only marked with the subject number, and will be disposed in a standardized manner after testing. Daytime function or daytime fatigue will be measured by the scale of Fatigue Scale (FS) at baseline, day 14 and day 28. FS consists of 14 items, each of which is a fatigue-related question, reflecting both physical fatigue and mental fatigue. Hyper-sleep reactivity is measured by The Ford Insomnia Stress Response Test (FIRST) at baseline, day 14 and day 28. FIRST is a self-reporting tool including nine items designed to assess sleep response, The minimum total score is 9 and the maximum is 36. Higher scores on the FIRST indicate a more highly reactive sleep system. Traditional Chinese Medicine(TCM) symptom score scale is used to evaluate the changes of patients' TCM symptoms at baseline, day 14 and day 28. Safety monitoring Patients will sign informed consent upon enrollment. Any adverse event related to acupuncture treatment, including pain, subcutaneous hematoma and fainting, will be reported by patients and doctors during each treatment. Adverse events of esazolam will also be monitored, recorded and reported. Besides, all participants will be detected blood routine, urine routine, liver and kidney function and ECG to exclude severe heart/liver/kidney diseases and evaluate the possible side effects of the treatments. In the event of serious adverse effects (AEs), we will stop the intervention and take timely rescue measures. The research group of this study will bear the corresponding medical expenses and provide the corresponding economic compensation. Data collection and management All researchers will be trained before the start of the study so that they can correctly grasp the content of the study protocol. Two research recorders are trained to fill the case report form (CRF) which includes general demographic information, clinical history, medication use, data from testing and evaluation, AEs, quantity of drugs recovered, etc. The data will be double entered in SPSS27.0 to ensure the accuracy. Personal data of participants will be kept confidential. Blood/urine/stool specimens will be identified by study number rather than name. Information that can identify the participants will not be disclosed to members outside the study group without their permission. CRFs will be kept in a locked filing cabinet and will be accessible only to researchers. In order to ensure that the study is conducted in accordance with the regulations, the members of the government administration or ethics committee may, as required, access the participants’ personal data at the research facility. When the results of this study are published, no identifying information of the participants will be disclosed. Statistical analysis All cases randomized and treated at least once will be analyzed. Statistical analyses of the clinical data will be performed using SPSS 27.0 statistical software (IBM Corporation, Armonk, NY, USA) and supervised by a skilled statistician blinded to group allocation. The Kolmogorov– Smirnov test will be used to test the normal distribution of continuous variables. Continuous normally distributed data will be reported as means and standard deviations; continuous non-normally distributed data will be expressed as medians with interquartile ranges. Categorical data will be presented as frequencies or percentages. For the demographic and clinical information at baseline, the chi-squared test or Fisher’s exact test will be used for comparison of dichotomous data. To compare baseline and post-treatment changes in the same group, we will use the paired t test. To compare the changes before and after treatment between the two groups, we will use the statistical analysis method of non-inferiority test. Quality control measures To ensure the quality of the clinical trial research project and control the risks, two quality supervisors from our team will supervise the intervention process, the authenticity of the data collection, and the occurrence of AEs every 3 months. They will write monitoring reports and give feedback to the research team to discuss whether to communicate important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses). Any important change should be reported to the participants, the funder, ethical committee, journals and trail registration website if necessary. [i] Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J,et al. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586 [ii] Yang L, Li YX, Yu XG, Li W, Zhang CC. Clinical effect of burying Wuzang Shu with press-needle and Ji-shu on insomnia. Journal of Practical Medicine.2021,37(13):1765-1768. [iii] Li HQ, Zhou HY, Guo J, Wei J, Cao KG. Treatment of 30 cases of primary insomnia by Chou's Tiaoshen acupuncture. Global Traditional Chinese Medicine. 2017,10(07):882-885. [iv] Sleep Disorders Group, Chinese Society of Neurology, Chinese Society of Neurology. China's diagnosis and treatment of adult insomnia guide (2017 edition). Chinese neurologist magazine, 2018 ploidy (5) : 324-335. Discussion According to the classic of TCM-Inner Canon of Yellow Emperor, insomnia is a consequence of the vicious cycle of “daytime low-spirit” and “night time hyperarousal state”. “Chou’s Tiaoshen” acupoints, which includes Baihui (GV-20), Shenting (GV-24), Benshen(BG-13), Sishencong (EX-HN1), Neiguan(PC-6), Shenmen (HT-7), and Sanyinjiao (SP-6)), is beneficial to restore the normal sleep-wake cycle by restoring the balance of energy (Yin and Yang), calming the Heart, and regulating the mentality. A review suggests that acupuncture can improve subjective sleep quantity and quality, as well as normalizing disordered sleep architecture . It also reflects that the mechanism of acupuncture for primary insomnia may be regulating the release of melatonin and its receptors, regulating orexin A neurons, regulating the hyperactive HPA axis et.al . However, the efficacy of acupuncture for short-term insomnia is uncertain. The aim of this study is to evaluate the clinical efficacy of “Chou’s Tiaoshen” acupoints for short-term insomnia. The hyperarousal hypothesis of insomnia suggests that in response to stress, our bodies make coping changes: HPA-axis function alters, cortisol concentrations improves, resting heart rate gets higher, slow wave and rapid eye movement sleep reduces . Therefore, insomnia is also regarded as a part of stress response, the physiological part of hyperarousal will help people better cope with stressful events. However, if this state of hyperarousal persists, it will become a pathological factor that leads to the persistence of insomnia. Another study has shown that patients with hyperarousal have a vulnerability in the central emotion-regulating network, and that failure to regulate emotions is responsible for the existence of an overexcited state and will lead to the insufficient REM-Sleep LC-NA (locus Coeruleus-noradrenaline) Silencing . Therefore this study will focus on the mechanism of hyperarousal in short-term insomnia by testing FIRST, serum cortisol, HRV and PSG to explore the mechanism of acupuncture on short-term insomnia. The innovation of this study is the provision of acupuncturing “Chou’s Tiaoshen” acupoints for short-term insomnia. The effective and normative intervention measure of short-term insomnia is limited and the mechanism is still unclear. CBT-I is the most recommended therapy for short-term insomnia. Due to the high cost, lack of professional staff and other reasons, CBT-I hasn’t been widely used in clinical practice. It’s suggested that acupuncture may be a potential effective treatment for short-term insomnia. This study will explore whether acupuncture can effectively treat short-term insomnia and provide evidence for clinical application. Based on the hyperarousal hypothesis of insomnia, we will also explore the effect mechanism of acupuncture. The limitation of this study is that it is difficult to design blind methods for acupuncture clinical trials, we only designed blind evaluation. We plan to publish the results in the form of a research paper after the trail. Abbreviations PSQI: Pittsburgh Sleep Quality Index; PSG: Polysomnography; HRV: Heart rate variability; FIRST: Ford Insomnia Response to Stress Test; TCM: Traditional Chinese Medicine; ICSD-3: International Classification of Sleep Disorders Third Edition; CBT-I: Cognitive behavioral therapy for insomnia; HPA: Hypothalamic-Pituitary-Adrenal; DSM-V: Diagnostic and Statistical Manual of Mental Disorders Text Revision, 5 th edition; AEs: Adverse effects; Declarations • Ethics approval and consent to participate This protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine (Bejing TCM Hospital), the approval number is 2023BL02-103-02. • Consent for publication Not applicable • Availability of data and materials Not applicable • Competing interests The authors declare that they have no competing interests. • Funding Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University Grant ID: LYZD202203 Contact name: Qingquan Liu Address: Backstreet Gallery No. 23 in Dongcheng District, Beijing, China Telephone: 010-52176506 Email: [email protected] • Authors' contributions H.L. has put forward the core conception and directed the research. 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Global Traditional Chinese Medicine. 2017,10(07):882-885. Sleep Disorders Group, Chinese Society of Neurology, Chinese Society of Neurology. China's diagnosis and treatment of adult insomnia guide (2017 edition). Chinese neurologist magazine, 2018 ploidy (5) : 324-335. Zhao F-Y, Spencer SJ, Kennedy GA, Zheng Z, Conduit R, Zhang W-J, et al. Acupuncture for primary insomnia: Effectiveness, safety, mechanisms and recommendations for clinical practice. Sleep Med Rev. 2023;74:101892. Zhao F-Y, Spencer SJ, Kennedy GA, Zheng Z, Conduit R, Zhang W-J, et al. Acupuncture for primary insomnia: Effectiveness, safety, mechanisms and recommendations for clinical practice. Sleep Med Rev. 2023;74:101892. Walker JL, Vargas I, Drake CL, Ellis JG, Muench A, Perlis ML. The natural history of insomnia: high sleep reactivity interacts with greater life stress to predict the onset of acute insomnia. Sleep. 2022;45:zsac149. Van Someren EJW. Brain mechanisms of insomnia: new perspectives on causes and consequences. Physiol Rev. 2021;101:995–1046. Additional Declarations No competing interests reported. Supplementary Files Spiritchecklist.doc Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4182329","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":286128191,"identity":"9e79fa4f-87c1-42e5-becd-17b2b62377dd","order_by":0,"name":"ZiYi Wong","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"ZiYi","middleName":"","lastName":"Wong","suffix":""},{"id":286128192,"identity":"25c1f932-4615-4fb6-a028-b426d21f199f","order_by":1,"name":"Qiuyang Hong","email":"","orcid":"","institution":"Shunyi Hospital of Beijing Traditional Chinese Medicine Hospital","correspondingAuthor":false,"prefix":"","firstName":"Qiuyang","middleName":"","lastName":"Hong","suffix":""},{"id":286128193,"identity":"b792409e-ef96-4891-ab2f-bbc56c18546a","order_by":2,"name":"Yeqing He","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Yeqing","middleName":"","lastName":"He","suffix":""},{"id":286128194,"identity":"6d009b02-b764-42cb-980c-01c64efc41e5","order_by":3,"name":"XiaoYu Yan","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"XiaoYu","middleName":"","lastName":"Yan","suffix":""},{"id":286128195,"identity":"531d3f3e-1e2c-432d-8051-e2e8457ad05a","order_by":4,"name":"Qian Liu","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Qian","middleName":"","lastName":"Liu","suffix":""},{"id":286128197,"identity":"c31a3432-0469-4f38-b3f5-818e502591ed","order_by":5,"name":"Mingyang Cao","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Mingyang","middleName":"","lastName":"Cao","suffix":""},{"id":286128200,"identity":"922d3020-00c6-4855-a59b-02fb54640cf1","order_by":6,"name":"Ruotong Zhao","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Ruotong","middleName":"","lastName":"Zhao","suffix":""},{"id":286128202,"identity":"459592df-54d0-460b-8cb9-80607302dde8","order_by":7,"name":"Yichen Fei","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Yichen","middleName":"","lastName":"Fei","suffix":""},{"id":286128204,"identity":"65bcb204-f17e-44d6-8116-eb979a9cce9d","order_by":8,"name":"Keren He","email":"","orcid":"","institution":"Beijing University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Keren","middleName":"","lastName":"He","suffix":""},{"id":286128205,"identity":"00f9f82b-9c76-4412-981b-5bb7dbed8ebe","order_by":9,"name":"Huanqin Li","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAp0lEQVRIiWNgGAWjYBACAwbGBgaGAgk5Nvb2A6RoMZAw5uM5k0CsFgiZOE/CwYA4LebsyW0PGAws0tskGBIYflRsI6zFsudhuwHQYblt0o0HGHvO3CbCYTcSgeaDtMgcSGBmbCNBSzqbRIIBaVoSSNBy5iFYi2EbMJAPEueX4+nPJBgq6uTl29sPPvhRQYQWBmDQMv+BMg8Qox6sZRSMglEwCkYBfgAAkgg2RLipHJwAAAAASUVORK5CYII=","orcid":"","institution":"Beijing Hospital of Traditional Chinese Medicine","correspondingAuthor":true,"prefix":"","firstName":"Huanqin","middleName":"","lastName":"Li","suffix":""}],"badges":[],"createdAt":"2024-03-28 12:42:00","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4182329/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4182329/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":54108901,"identity":"7b6c62d4-8650-4ac9-b927-d86cba7f30ae","added_by":"auto","created_at":"2024-04-04 17:40:10","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":36180,"visible":true,"origin":"","legend":"\u003cp\u003eThe schedule of enrolment, interventions, and assessments.*\u003c/p\u003e\n\u003cp\u003e*Recommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration for examples from protocols.\u003c/p\u003e\n\u003cp\u003e**List specific timepoints in this row.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-4182329/v1/d2fd32c4ad760c2a133d716a.png"},{"id":55265041,"identity":"608b0fd7-c2fe-48df-aef2-e17dfb90db11","added_by":"auto","created_at":"2024-04-25 01:54:25","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":434866,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4182329/v1/a8986590-5834-4b45-8018-3fc5f27ae54c.pdf"},{"id":54108902,"identity":"233226e2-4604-4289-9c76-0e4b7ebee622","added_by":"auto","created_at":"2024-04-04 17:40:11","extension":"doc","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":121856,"visible":true,"origin":"","legend":"","description":"","filename":"Spiritchecklist.doc","url":"https://assets-eu.researchsquare.com/files/rs-4182329/v1/d147e6ec91c0765f71c8df4c.doc"}],"financialInterests":"No competing interests reported.","formattedTitle":"A study of acupuncturing “Chou’s Tiaoshen” acupoints on short-term insomnia patients: study protocol for a randomized controlled trial","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003eAccording to International Classification of Sleep Disorders Third Edition (ICSD-3) diagnostic criteria\u003ca class=\"FNLink\" href=\"#Fn1\" id=\"#FNLinkFn1\"\u003e\u003c/a\u003e, short-term insomnia is defined as difficulty in falling asleep or staying asleep, as well as daytime dysfunction in the presence of adequate sleep opportunities, and these symptoms occur for less than 3 months. The annual prevalence of short-term insomnia has been found to be 27%, with 19% of these patients continuing to have poor sleep and developing into chronic insomnia\u003ca class=\"FNLink\" href=\"#Fn2\" id=\"#FNLinkFn2\"\u003e\u003c/a\u003e. Another study has shown that 1 in 5 patients with short-term insomnia will progress to chronic insomnia\u003ca class=\"FNLink\" href=\"#Fn3\" id=\"#FNLinkFn3\"\u003e\u003c/a\u003e. An article titled \"Insomnia\" published in the Lancet in 2022 states that the best time for medical management of insomnia is 2 or more weeks after the onset of insomnia\u003ca class=\"FNLink\" href=\"#Fn4\" id=\"#FNLinkFn4\"\u003e\u003c/a\u003e. Timely intervention of short-term insomnia is of great significance in preventing it from developing into chronic insomnia and decreasing the heavy health burden. Insomnia is associated with the negative consequences of many diseases, such as cardiovascular diseases, cancer, hypertension, and diabetes\u003ca class=\"FNLink\" href=\"#Fn5\" id=\"#FNLinkFn5\"\u003e\u003c/a\u003e. It is also associated with higher rates of workplace injuries and traffic accidents \u003ca class=\"FNLink\" href=\"#Fn6\" id=\"#FNLinkFn6\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn7\" id=\"#FNLinkFn7\"\u003e\u003c/a\u003e. The direct and indirect losses it causes each year exceed 100\u0026nbsp;billion dollars annually, much higher than other mental illnesses\u003ca class=\"FNLink\" href=\"#Fn8\" id=\"#FNLinkFn8\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn9\" id=\"#FNLinkFn9\"\u003e\u003c/a\u003e.\u003c/p\u003e \u003cp\u003eThe control of short-term insomnia has been has been paid more and more attention by scholars, but the treatment of short-term insomnia has not made a breakthrough due to the lack of patient's understanding of short-term insomnia as well as the adverse reaction of drug. At present, most scholars believe that short-term insomnia is mainly treated with non-drug therapy, such as cognitive behavioral therapy for insomnia(CBT-I), which intends to improve sleep by changing the patient's poor sleep beliefs and behaviors. However, there is a lack of professional practitioners and each treatment takes a lot of time, CBT-I has not been effectively carried out in clinical practice. Benzodiazepines such as estazolam are used only when insomnia produces severe and incurable personal stress, but the adverse reaction of applying the above drugs will unavoidably occur in varying degrees\u003ca class=\"FNLink\" href=\"#Fn10\" id=\"#FNLinkFn10\"\u003e\u003c/a\u003e. Therefore, in-depth research on short-term insomnia, searching for more effective treatments with fewer side effects, and exploring the acting factors of efficacy are extremely important for the management and prevention of short-term insomnia.\u003c/p\u003e \u003cp\u003eAcupuncture, the most original and advantageous non-drug therapy in China, is convenient, inexpensive, effective, and has few side effects, and is now being used more and more in the international arena. A recent review\u003ca class=\"FNLink\" href=\"#Fn11\" id=\"#FNLinkFn11\"\u003e\u003c/a\u003e shows that acupuncture can improves both subjective sleep quality and objective sleep processes, it also suggested that the most commonly adopted acupoints for treating primary insomnia are Shenmen (HT7), Baihui (GV20), and Sanyinjiao (SP6). \u0026ldquo;Chou\u0026rsquo;s Tiaoshen\u0026rdquo; acupoints(including Baihui (GV-20), Shenting (GV-24), Benshen(BG-13), Sishencong (EX-HN1), Neiguan(PC-6), Shenmen (HT-7), and Sanyinjiao (SP-6)), derived from the experience of a national famous veteran traditional Chinese medicine practitioner of our department, has achieved good efficacy in the preliminary studies related to insomnia, which can improve both the nighttime sleep quality of the patients and their daytime awakening state\u003ca class=\"FNLink\" href=\"#Fn12\" id=\"#FNLinkFn12\"\u003e\u003c/a\u003e\u003csup\u003e,\u003c/sup\u003e\u003ca class=\"FNLink\" href=\"#Fn13\" id=\"#FNLinkFn13\"\u003e\u003c/a\u003e.\u003c/p\u003e \u003cp\u003eThe etiology of short-term insomnia is unclear and cannot be attributed to a single source, but involves multiple environmental, genetic, psychological, and behavioral factors, but there is a developing consensus that short-term insomnia is a \u0026ldquo;hyperarousal\u0026rdquo; disorder\u003ca class=\"FNLink\" href=\"#Fn14\" id=\"#FNLinkFn14\"\u003e\u003c/a\u003e. Bonnet first proposed the mechanism hypothesis of hyperarousal in 1997\u003ca class=\"FNLink\" href=\"#Fn15\" id=\"#FNLinkFn15\"\u003e\u003c/a\u003e. Hyperarousal refer to overreaction to sleep stress stimuli. Hyperarousal can be manifested in faster electrical brain frequency reflected by electroencephalogram, increased functional activity of the autonomic nervous system, over activity of the hypothalamic-pituitary-adrenal axis, and the release of inflammatory factors. More and more studies have shown that high sleep reactivity is an important cause of acute insomnia\u003ca class=\"FNLink\" href=\"#Fn16\" id=\"#FNLinkFn16\"\u003e\u003c/a\u003e. Compared to participants with low sleep reactivity, participants with high sleep reactivity were 76% more likely to develop acute insomnia within a year\u003ca class=\"FNLink\" href=\"#Fn17\" id=\"#FNLinkFn17\"\u003e\u003c/a\u003e. People with highly reactive poor sleep are two to three times more likely to develop chronic insomnia than people with non-reactive poor sleep\u003ca class=\"FNLink\" href=\"#Fn18\" id=\"#FNLinkFn18\"\u003e\u003c/a\u003e. FIRST (Ford Insomnia Response to Stress Test) is a kind of self- reporting tools to assess sleep reaction\u003ca class=\"FNLink\" href=\"#Fn19\" id=\"#FNLinkFn19\"\u003e\u003c/a\u003e. Heart Rate Variability (HRV) can respond to the enhanced symptomatic activity of sleep, which is related to the hyperarousal state of the central nervous system of patients with insomnia\u003ca class=\"FNLink\" href=\"#Fn20\" id=\"#FNLinkFn20\"\u003e\u003c/a\u003e. Serum cortisol can reflect the functional status of the Hypothalamic-Pituitary-Adrenal axis (HPA axis), a pivot of the body's response to stress\u003ca class=\"FNLink\" href=\"#Fn21\" id=\"#FNLinkFn21\"\u003e\u003c/a\u003eincluding insomnia, and participates in the regulation of sleep homeostasis, and also plays an important role in the promotion of arousal and the regulation of sleep\u003ca class=\"FNLink\" href=\"#Fn22\" id=\"#FNLinkFn22\"\u003e\u003c/a\u003e.It\u0026rsquo;s also shown that hyper reactive sleepers have decreased REM sleep and increased nighttime wakefulness under stress (especially during REM sleep)\u003ca class=\"FNLink\" href=\"#Fn23\" id=\"#FNLinkFn23\"\u003e\u003c/a\u003e.\u003c/p\u003e \u003cp\u003eIn summary, there are few studies on short-term insomnia, and effective and timely intervention is often not available, which brings serious disease burden. The mechanism is still not clear, and recent studies suggest that short-term insomnia is associated with hyperarousal. In this study, we designed a randomized controlled trial comparing acupuncturing \u0026ldquo;Chou\u0026rsquo;s Tiaoshen\u0026rdquo; acupoints on short-term insomnia patients with estazolam. We chose Pittsburgh Sleep Quality Index (PSQI) as the primary outcome measure to explore the effect of acupuncture on short-term insomnia. We also focus on the mechanism of hyperarousal in short-term insomnia by testing FIRST, serum cortisol, HRV and polysomnography (PSG) to explore the mechanism of acupuncture on short-term insomnia.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003e\u003cstrong\u003eTrail design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis is a multi-center, randomized controlled, blind evaluated and non-inferiority study, with estazolam as a control, aiming to explore whether \u0026ldquo;Chou\u0026rsquo;s Tiaoshen\u0026rdquo; acupoints is non-inferior to estazolam and the possible mechanism of acupuncture for short-term insomnia. A total of 88 participants will be randomly assigned to two different groups. Participants will receive acupuncturing \u0026ldquo;Chou\u0026rsquo;s Tiaoshen\u0026rdquo; acupoints in the acupuncture group five times a week and last for 2 weeks. While participants in the estazolam group will take estazolam before bedtime in the day and the treatment will also be given for 2 weeks. Polysomnography, heart rate variability, cortisol and related scales will be measured before and after treatment to detect the changes in symptoms and signs. The time schedule can be seen in figure 1. This protocol is reported based on the SPIRIT guidelines[i] (the SPIRIT checklist of this protocol is available in the supplementary material).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants and recruitment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants with short-term insomnia will be recruited from the outpatient clinic at two different wards of Beijing TCM Hospital ( Dongcheng ward and Shunyi ward) from 2024.3 to 2025.3.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size estimation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAccording to the existing literature[ii], estazolam treatment for insomnia can make PSQI score decrease 5.51 \u0026plusmn; 3.37 than before. According to our previous work[iii], acupuncturing \u0026ldquo;Chou\u0026rsquo;s Tiaoshen\u0026rdquo; acupoints for insomnia can make PSQI score decreased 5.17 \u0026plusmn; 3.55 than before. Therefore, the non-inferiority test was used in this study, and the non-inferiority threshold \u0026ldquo;\u0026Delta;\u0026rdquo; was set as \u0026ldquo;-2\u0026rdquo;. The test level is set as \u0026alpha; =0.025 (one side), the test efficiency is 1- \u0026beta; =0.80, and the sample size calculation formula is based on the comparing of means of the two samples. It was calculated that a minimum of 35 patients will be required in each group. Considering lost follow-up, excluded and detached cases (controlled below 20%), it requires the sample size of at least 44 cases in each group and the total sample size of at least 88 cases.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1. Meet the diagnostic criteria for short-term insomnia according to the Diagnostic and Statistical Manual of Mental Disorders Text Revision, 5\u003csup\u003eth\u003c/sup\u003e edition (DSM-V) and Chinese Adult Insomnia Diagnosis and Treatment Guide 2017[iv]: A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms: 1)Difficulty initiating sleep. 2). Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings. 3) Early-morning awakening with inability to return to sleep. 4) The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. The duration of the sleep difficulty is 1 week to 3 months.\u003c/p\u003e\n\u003cp\u003e2. Aged between 18 and 70 years old. Male or female.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e3. Patients who agreed to participant in this trial and assigned the informed consent (Available in the related files).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1. People with other DSM-V Axis I, Axis II mental disorders or substance abuse/dependence.\u003c/p\u003e\n\u003cp\u003e2. Patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, hypertension, digestive system, hematopoietic system, liver, kidney, or severe anxiety and depression.\u003c/p\u003e\n\u003cp\u003e3. Caused by alcohol or drugs.\u003c/p\u003e\n\u003cp\u003e4. Pregnant or lactating women.\u003c/p\u003e\n\u003cp\u003e5. Easy to combine infection and bleeding.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e6. Patients who have used psychotropic drugs, such as antidepressants, mania drugs or other drugs used to treat psychosis, in the last month, and patients who have taken sleeping pills in the last 1 month.\u003c/p\u003e\n\u003cp\u003e7. Those who cannot cooperate with treatment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eElimination criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTake other anti-insomnia drugs or other treatments during the observation period.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eShedding criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1. Quit due to poor efficacy or sever adverse effects;\u003c/p\u003e\n\u003cp\u003e2. Patients who were lost to follow-up.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRandomization and allocation concealment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe included participants were divided into acupuncture group or estazolam group according to the randomization principle. The group randomization method generated random number table using SPSS 20.0 software, corresponding group code into envelopes and sealed (unrecoverable after unpacking). The allocation ratio of the two groups is 1:1. Random envelopes are made by special personnel to achieve covert grouping. Qualified patients were enrolled according to the randomized protocol. The number of the randomized envelope is the serial number of the patients enrolled. Select in the order of small to large, open the randomized envelope, and operate according to the prompts in the randomized envelope. We will keep the concealment of the randomized method during the trials.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBlinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIt is difficult to blind the researchers and participants in this study, we only perform blinded evaluation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProvisions for concomitant medication or treatment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAllowed concomitant medication / treatment: In the course of the trial, the medication of the Pre-existing disease, such as coronary heart disease, diabetes mellitus and hyperlipidemia, can be remain unchanged, and the combined medication of the subjects should be recorded in detail. Concomitant medication / treatment prohibited: other anti-insomnia drugs or other insomnia treatment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcupuncture group\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;Chou\u0026rsquo;s Tiaoshen\u0026rdquo; acupoints include Baihui (GV-20), Shenting (GV-24), Benshen(BG-13), Sishencong (EX-HN1), Neiguan(PC-6), Shenmen (HT-7), \u0026nbsp; and Sanyinjiao (SP-6). Using stainless steel needles (0.18\u0026times;40 mm, HuaTuo, China). Then some other points like, Taichong (LR3), Daling(PC-7), Danzhong(CV-17), Taixi (KI-3), Qihai (CV-6), and Qiuxu(GB-40) are chosen based on participant\u0026rsquo;s unique pattern. Operation: Patients in supine position. Baihui (GV-20), Shenting (GV-24), Benshen(BG-13), and Sishencong (EX-HN1) are punctured at a depth of 5-10mm obliquely. Neiguan(PC-6), Sanyinjiao (SP-6), and Shenmen (HT-7) are inserted 10-15mm perpendicularly. Until feeling tactile sensation then manually manipulated by rotation methods to produce a characteristic sensation known is known as \u0026quot;De Qi\u0026quot;. Technique: Mild reinforcing and attenuating, retaining the needle for 30minutes. The treatment will be given once a day and 5 times a week in weekdays, the course will last 2 weeks.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEstazolam group\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants will take estazolam tablets (1 mg/day) 30min prior to bedtime. The course will last 2 weeks.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePrimary outcome measure\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSleep quality will be measured using the scale of Pittsburgh Sleep Quality Index (PSQI) at baseline, day 14 and day 28. PSQI is a self-rated questionnaire which assesses sleep quality and disturbances. Eighteen individual items generate seven \u0026ldquo;component\u0026rdquo; scores: subjective sleep quality (SQ), sleep-onset latency (SOL), total sleep time (TST), habitual sleep efficiency (SE), sleep disturbances ( Dyssomnia), use of sleeping medication, and daytime dysfunction (DD).The cumulative component score is the PSQI total score ranging from 0 to 21, higher scores indicates worse sleep quality.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSecondary outcome measures\u003c/strong\u003e\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eObjectivity sleep quality and related sleep events are measured by polysomniography (PSG) at baseline and day 14. PSG is a classic instrument for detecting sleep conditions. The following data can be obtained by PSG monitoring: total sleep time, sleep latency, The percentage of time spent in each sleep stage. Previous studies have shown differences between subjective and objective sleep. PSG is of great value for the degree and differential diagnosis of insomnia.\u003c/li\u003e\n \u003cli\u003eHeart rate variability (HRV) is used to assess autonomic tone at baseline and day 14. The degree and regularity of heart rate changes can be reflected by measuring the variability of continuous normal R-R interphase changes by dynamic electrocardiogram, so as to judge its impact on cardiovascular activities, which can reflect the activity of autonomic nervous system and quantitatively evaluate the balance of sympathetic and vagal nerve tension.\u003c/li\u003e\n \u003cli\u003eSerum cortisol is used to assess autonomic tone at baseline and day 14. Cortisol changes in the body in a circadian rhythm and we will test serum cortisol at 8 am.\u0026nbsp;Serum cortisol is elevated during stress, which can reflect excessive arousal. The serum samples are only marked with the subject number, and will be disposed in a standardized manner after testing.\u003c/li\u003e\n \u003cli\u003eDaytime function or daytime fatigue will be measured by the scale of Fatigue Scale (FS) at baseline, day 14 and day 28. FS consists of 14 items, each of which is a fatigue-related question, reflecting both physical fatigue and mental fatigue.\u003c/li\u003e\n \u003cli\u003eHyper-sleep reactivity is measured by The Ford Insomnia Stress Response Test (FIRST) at baseline, day 14 and day 28. FIRST is a self-reporting tool including nine items designed to assess sleep response, The minimum total score is 9 and the maximum is 36. Higher scores on the FIRST indicate a more highly reactive sleep system.\u003c/li\u003e\n \u003cli\u003eTraditional Chinese Medicine(TCM) symptom score scale is used to evaluate the changes of patients\u0026apos; TCM symptoms at baseline, day 14 and day 28.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eSafety monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients will sign informed consent upon enrollment. Any adverse event related to acupuncture treatment, including pain, subcutaneous hematoma and fainting, will be reported by patients and doctors during each treatment. Adverse events of esazolam will also be monitored, recorded and reported. Besides, all participants will be detected \u0026nbsp; \u0026nbsp;blood routine, urine routine, liver and kidney function and ECG to exclude severe heart/liver/kidney diseases and evaluate the possible side effects of the treatments. In the event of serious adverse effects (AEs), we will stop the intervention and take timely rescue measures. The research group of this study will bear the corresponding medical expenses and provide the corresponding economic compensation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData collection and management\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll researchers will be trained before the start of the study so that they can correctly grasp the content of the study protocol. Two research recorders are trained to fill the case report form (CRF) which includes general demographic information, clinical history, medication use, data from testing and evaluation, AEs, quantity of drugs recovered, etc. The data will be double entered in SPSS27.0 to ensure the accuracy.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePersonal data of participants will be kept confidential. Blood/urine/stool specimens will be identified by study number rather than name. Information that can identify the participants will not be disclosed to members outside the study group without their permission. CRFs will be kept in a locked filing cabinet and will be accessible only to researchers. In order to ensure that the study is conducted in accordance with the regulations, the members of the government administration or ethics committee may, as required, access the participants\u0026rsquo; personal data at the research facility. When the results of this study are published, no identifying information of the participants will be disclosed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll cases randomized and treated at least once will be analyzed. Statistical analyses of the clinical data will be performed using SPSS 27.0 statistical software (IBM Corporation, Armonk, NY, USA) and supervised by a skilled statistician blinded to group allocation. The Kolmogorov\u0026ndash; Smirnov test will be used to test the normal distribution of continuous variables. Continuous normally distributed data will be reported as means and standard deviations; continuous non-normally distributed data will be expressed as medians with interquartile ranges. Categorical data will be presented as frequencies or percentages. For the demographic and clinical information at baseline, the chi-squared test or Fisher\u0026rsquo;s exact test will be used for comparison of dichotomous data. To compare baseline and post-treatment changes in the same group, we will use the paired t test. To compare the changes before and after treatment between the two groups, we will use the statistical analysis method of non-inferiority test.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQuality control measures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo ensure the quality of the clinical trial research project and control the risks, two quality supervisors from our team will supervise the intervention process,\u0026nbsp;the authenticity of the data collection, and the occurrence of AEs\u0026nbsp;every 3 months. They will write monitoring reports and give feedback to the research team to discuss whether to communicate important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses). Any important change should be reported to the participants, the funder, ethical committee, journals and trail registration website if necessary.\u003c/p\u003e\n\u003cp\u003e[i] Chan A-W, Tetzlaff JM, G\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin J,et al. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586\u003c/p\u003e\n\u003cdiv id=\"edn1\"\u003e\n \u003cp\u003e[ii] Yang L, Li YX, Yu XG, Li W, Zhang CC. Clinical effect of burying Wuzang Shu with press-needle and Ji-shu on insomnia. Journal of Practical Medicine.2021,37(13):1765-1768.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"edn2\"\u003e\n \u003cp\u003e[iii] Li HQ, Zhou HY, Guo J, Wei J, Cao KG. Treatment of 30 cases of primary insomnia by Chou\u0026apos;s Tiaoshen acupuncture. Global Traditional Chinese Medicine. 2017,10(07):882-885.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"edn3\"\u003e\n \u003cp\u003e[iv] Sleep Disorders Group, Chinese Society of Neurology, Chinese Society of Neurology. China\u0026apos;s diagnosis and treatment of adult insomnia guide (2017 edition). Chinese neurologist magazine, 2018 ploidy (5) : 324-335.\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eAccording to the classic of TCM-Inner Canon of Yellow Emperor, insomnia is a consequence of the vicious cycle of \u0026ldquo;daytime low-spirit\u0026rdquo; and \u0026ldquo;night time hyperarousal state\u0026rdquo;. \u0026ldquo;Chou\u0026rsquo;s Tiaoshen\u0026rdquo; acupoints, which includes Baihui (GV-20), Shenting (GV-24), Benshen(BG-13), Sishencong (EX-HN1), Neiguan(PC-6), Shenmen (HT-7), and Sanyinjiao (SP-6)), is beneficial to restore the normal sleep-wake cycle by restoring the balance of energy (Yin and Yang), calming the Heart, and regulating the mentality. A review suggests that acupuncture can improve subjective sleep quantity and quality, as well as normalizing disordered sleep architecture\u003ca class=\"FNLink\" href=\"#Fn28\" id=\"#FNLinkFn28\"\u003e\u003c/a\u003e. It also reflects that the mechanism of acupuncture for primary insomnia may be regulating the release of melatonin and its receptors, regulating orexin A neurons, regulating the hyperactive HPA axis et.al\u003ca class=\"FNLink\" href=\"#Fn29\" id=\"#FNLinkFn29\"\u003e\u003c/a\u003e. However, the efficacy of acupuncture for short-term insomnia is uncertain. The aim of this study is to evaluate the clinical efficacy of \u0026ldquo;Chou\u0026rsquo;s Tiaoshen\u0026rdquo; acupoints for short-term insomnia.\u003c/p\u003e \u003cp\u003eThe hyperarousal hypothesis of insomnia suggests that in response to stress, our bodies make coping changes: HPA-axis function alters, cortisol concentrations improves, resting heart rate gets higher, slow wave and rapid eye movement sleep reduces\u003ca class=\"FNLink\" href=\"#Fn30\" id=\"#FNLinkFn30\"\u003e\u003c/a\u003e. Therefore, insomnia is also regarded as a part of stress response, the physiological part of hyperarousal will help people better cope with stressful events. However, if this state of hyperarousal persists, it will become a pathological factor that leads to the persistence of insomnia. Another study has shown that patients with hyperarousal have a vulnerability in the central emotion-regulating network, and that failure to regulate emotions is responsible for the existence of an overexcited state and will lead to the insufficient REM-Sleep LC-NA (locus Coeruleus-noradrenaline) Silencing\u003ca class=\"FNLink\" href=\"#Fn31\" id=\"#FNLinkFn31\"\u003e\u003c/a\u003e. Therefore this study will focus on the mechanism of hyperarousal in short-term insomnia by testing FIRST, serum cortisol, HRV and PSG to explore the mechanism of acupuncture on short-term insomnia.\u003c/p\u003e \u003cp\u003eThe innovation of this study is the provision of acupuncturing \u0026ldquo;Chou\u0026rsquo;s Tiaoshen\u0026rdquo; acupoints for short-term insomnia. The effective and normative intervention measure of short-term insomnia is limited and the mechanism is still unclear. CBT-I is the most recommended therapy for short-term insomnia. Due to the high cost, lack of professional staff and other reasons, CBT-I hasn\u0026rsquo;t been widely used in clinical practice. It\u0026rsquo;s suggested that acupuncture may be a potential effective treatment for short-term insomnia. This study will explore whether acupuncture can effectively treat short-term insomnia and provide evidence for clinical application. Based on the hyperarousal hypothesis of insomnia, we will also explore the effect mechanism of acupuncture. The limitation of this study is that it is difficult to design blind methods for acupuncture clinical trials, we only designed blind evaluation. We plan to publish the results in the form of a research paper after the trail.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003ePSQI: Pittsburgh Sleep Quality Index; PSG: Polysomnography; HRV: Heart rate variability; FIRST: Ford Insomnia Response to Stress Test; TCM: Traditional Chinese Medicine; ICSD-3: International Classification of Sleep Disorders Third Edition; CBT-I: Cognitive behavioral therapy for insomnia; HPA: Hypothalamic-Pituitary-Adrenal;\u0026nbsp;DSM-V: Diagnostic and Statistical Manual of Mental Disorders Text Revision, 5\u003csup\u003eth\u003c/sup\u003e edition; AEs: Adverse effects;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e•\u0026nbsp;Ethics approval and consent to participate\u003c/p\u003e\n\u003cp\u003eThis protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine (Bejing TCM Hospital), the approval number is 2023BL02-103-02.\u003c/p\u003e\n\u003cp\u003e•\u0026nbsp;Consent for publication\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e•\u0026nbsp;Availability of data and materials\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e•\u0026nbsp;Competing interests\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e•\u0026nbsp;Funding\u003c/p\u003e\n\u003cp\u003eBeijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University\u003c/p\u003e\n\u003cp\u003eGrant ID: LYZD202203\u003c/p\u003e\n\u003cp\u003eContact name: Qingquan Liu\u003c/p\u003e\n\u003cp\u003eAddress: Backstreet Gallery No. 23 in Dongcheng District, Beijing, China\u003c/p\u003e\n\u003cp\u003eTelephone: 010-52176506\u003c/p\u003e\n\u003cp\u003eEmail:[email protected]\u003c/p\u003e\n\u003cp\u003e•\u0026nbsp;Authors' contributions\u003c/p\u003e\n\u003cp\u003eH.L. has put forward the core conception and directed the research. Z.W. and Q.H. have drafted the work and substantively revised it. Y.H.,X.Y., Q.L., M.C. and Y. F. initiated the study design. R.Z. produced additional documents. K.H. provided statistical expertise in clinical trial design. All authors contributed to refinement of the study protocol and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e•\u0026nbsp;Acknowledgements\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e•\u0026nbsp;Peer-review reports\u003c/p\u003e\n\u003cp\u003eIt has undergone independent peer-review from Beijing TCM Hospital (Peer-review reports is available in related files)\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSateia MJ. International classification of sleep disorders-third edition: highlights and modifications. Chest. 2014;146:1387\u0026ndash;94.\u003c/li\u003e\n\u003cli\u003ePerlis ML, Vargas I, Ellis JG, Grandner MA, Morales KH, Gencarelli A, et al. The Natural History of Insomnia: the incidence of acute insomnia and subsequent progression to chronic insomnia or recovery in good sleeper subjects. Sleep. 2020;43:zsz299.\u003c/li\u003e\n\u003cli\u003eDopheide JA. Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. Am J Manag Care. 2020;26 4 Suppl:S76\u0026ndash;84.\u003c/li\u003e\n\u003cli\u003ePerlis ML, Posner D, Riemann D, Bastien CH, Teel J, Thase M. Insomnia. Lancet. 2022;400:1047\u0026ndash;60.\u003c/li\u003e\n\u003cli\u003eHafner M, Stepanek M, Taylor J, Troxel WM, van Stolk C. Why Sleep Matters-The Economic Costs of Insufficient Sleep: A Cross-Country Comparative Analysis. Rand Health Q. 2017;6:11.\u003c/li\u003e\n\u003cli\u003eKessler RC, Berglund PA, Coulouvrat C, Hajak G, Roth T, Shahly V, et al. Insomnia and the performance of US workers: results from the America insomnia survey. Sleep. 2011;34:1161\u0026ndash;71.\u003c/li\u003e\n\u003cli\u003eGarbarino S, Magnavita N, Guglielmi O, Maestri M, Dini G, Bersi FM, et al. Insomnia is associated with road accidents. Further evidence from a study on truck drivers. PLoS One. 2017;12:e0187256.\u003c/li\u003e\n\u003cli\u003eWinkelman JW. CLINICAL PRACTICE. Insomnia Disorder. N Engl J Med. 2015;373:1437\u0026ndash;44.\u003c/li\u003e\n\u003cli\u003eWickwire EM, Shaya FT, Scharf SM. Health economics of insomnia treatments: The return on investment for a good night\u0026rsquo;s sleep. Sleep Med Rev. 2016;30:72\u0026ndash;82.\u003c/li\u003e\n\u003cli\u003eAntai-Otong D. The art of prescribing. Risks and benefits of non-benzodiazepine receptor agonists in the treatment of acute primary insomnia in older adults. Perspect Psychiatr Care. 2006;42:196\u0026ndash;200.\u003c/li\u003e\n\u003cli\u003eZhao F-Y, Spencer SJ, Kennedy GA, Zheng Z, Conduit R, Zhang W-J, et al. Acupuncture for primary insomnia: Effectiveness, safety, mechanisms and recommendations for clinical practice. Sleep Med Rev. 2023;74:101892.\u003c/li\u003e\n\u003cli\u003eLi H-Q, Zou Y-H, Guo J, Wei J, Cao K-G. Treatment of 30 cases of primary insomnia by Zhou\u0026apos;s acupuncture method [J]. Global Chinese Medicine,2017,10(07):882-885.\u003c/li\u003e\n\u003cli\u003eLi L, Liu R, Zhang T, Guo J, Chen H. Effects of acupuncture on sleep quality and hyperarousal in patients with primary insomnia [J]. Shanghai Journal of Acupuncture and Moxibustion,2019,38(09):973-977.\u003c/li\u003e\n\u003cli\u003eMorin CM. Definition of acute insomnia: diagnostic and treatment implications. Sleep Med Rev. 2012;16:3\u0026ndash;4.\u003c/li\u003e\n\u003cli\u003eLevenson JC, Kay DB, Buysse DJ. The pathophysiology of insomnia. Chest. 2015;147:1179\u0026ndash;92.\u003c/li\u003e\n\u003cli\u003eBuysse DJ. Insomnia. JAMA. 2013 Feb 20, 309(7):706-16. \u003c/li\u003e\n\u003cli\u003ePetersen H, Kecklund G, D\u0026rsquo;Onofrio P, Nilsson J, \u0026Aring;kerstedt T. Stress vulnerability and the effects of moderate daily stress on sleep polysomnography and subjective sleepiness. J Sleep Res. 2013;22:50\u0026ndash;7.\u003c/li\u003e\n\u003cli\u003eWalker JL, Vargas I, Drake CL, Ellis JG, Muench A, Perlis ML. The natural history of insomnia: high sleep reactivity interacts with greater life stress to predict the onset of acute insomnia. Sleep. 2022;45:zsac149.\u003c/li\u003e\n\u003cli\u003eKalmbach DA, Pillai V, Arnedt JT, Drake CL. Identifying At-Risk Individuals for Insomnia Using the Ford Insomnia Response to Stress Test. Sleep. 2016;39:449-456.\u003c/li\u003e\n\u003cli\u003eCovassin N, de Zambotti M, Sarlo M, De Min Tona G, Sarasso S, Stegagno L. Cognitive performance and cardiovascular markers of hyperarousal in primary insomnia. Int J Psychophysiol. 2011;80:79\u0026ndash;86.\u003c/li\u003e\n\u003cli\u003eZhou X-L, Rao Y-W. Changes of hypothalamic-pituitary-adrenal axis function in patients under stress [J]. Medical Review,2014,20(13):2439-2440.\u003c/li\u003e\n\u003cli\u003eZhou M. Study on the correlation between the changes of HPA axis function and TCM syndrome types in patients with metabolic syndrome with sleep disorders [D]. Sichuan: Chengdu University of Chinese Medicine,2019.\u003c/li\u003e\n\u003cli\u003eKalmbach DA, Anderson JR, Drake CL. The impact of stress on sleep: Pathogenic sleep reactivity as a vulnerability to insomnia and circadian disorders. J Sleep Res. 2018;27:e12710.\u003c/li\u003e\n\u003cli\u003eChan A-W, Tetzlaff JM, G\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin J,et al. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586\u003c/li\u003e\n\u003cli\u003eYang L, Li YX, Yu XG, Li W, Zhang CC. Clinical effect of burying Wuzang Shu with press-needle and Ji-shu on insomnia. Journal of Practical Medicine.2021,37(13):1765-1768.\u003c/li\u003e\n\u003cli\u003eLi HQ, Zhou HY, Guo J, Wei J, Cao KG. Treatment of 30 cases of primary insomnia by Chou\u0026apos;s Tiaoshen acupuncture. Global Traditional Chinese Medicine. 2017,10(07):882-885.\u003c/li\u003e\n\u003cli\u003eSleep Disorders Group, Chinese Society of Neurology, Chinese Society of Neurology. China\u0026apos;s diagnosis and treatment of adult insomnia guide (2017 edition). Chinese neurologist magazine, 2018 ploidy (5) : 324-335.\u003c/li\u003e\n\u003cli\u003eZhao F-Y, Spencer SJ, Kennedy GA, Zheng Z, Conduit R, Zhang W-J, et al. Acupuncture for primary insomnia: Effectiveness, safety, mechanisms and recommendations for clinical practice. Sleep Med Rev. 2023;74:101892.\u003c/li\u003e\n\u003cli\u003eZhao F-Y, Spencer SJ, Kennedy GA, Zheng Z, Conduit R, Zhang W-J, et al. Acupuncture for primary insomnia: Effectiveness, safety, mechanisms and recommendations for clinical practice. Sleep Med Rev. 2023;74:101892.\u003c/li\u003e\n\u003cli\u003eWalker JL, Vargas I, Drake CL, Ellis JG, Muench A, Perlis ML. The natural history of insomnia: high sleep reactivity interacts with greater life stress to predict the onset of acute insomnia. Sleep. 2022;45:zsac149.\u003c/li\u003e\n\u003cli\u003eVan Someren EJW. Brain mechanisms of insomnia: new perspectives on causes and consequences. Physiol Rev. 2021;101:995\u0026ndash;1046.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Short-term insomnia, Acupuncture, hyperarousal","lastPublishedDoi":"10.21203/rs.3.rs-4182329/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4182329/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e The incidence of short-term insomnia is high. Timely intervention of short-term insomnia has important significance to prevent it from developing into chronic insomnia which can lead to a heavy health burden. At present, the treatment of short-term insomnia is limited. Acupuncture is an effective and mature treatment for insomnia with a long history in China and is increasingly recognized internationally. However, there are few studies on short-term insomnia and no clinical studies on acupuncture treatment of short-term insomnia reported.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eOur team intends to conduct a randomized controlled trial to compare the \"Chou’s Tiaoshen\" acupuncture method with estazolam to explore the effectiveness of acupuncture in the treatment of short-term insomnia. A total of 88 eligible patients with short-term insomnia will be randomized in a ratio of 1:1 to the acupuncture group (\"Chou’s Tiaoshen\" acupoints) and estazolam group. The primary outcome measure is Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures are Polysomnography (PSG), heart rate variability (HRV), serum cortisol, Ford Insomnia Response to Stress Test (FIRST), daytime functional scale, Traditional Chinese Medicine（TCM） symptom scoring Scale. Clinical assessments will be performed both at baseline and after treatment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e This study aims to explore the therapeutic effect of acupuncture in the treatment of short-term insomnia. Furthermore, more and more studies have suggested that compared with chronic insomnia, short-term insomnia is more related to hyperarousal. We will explore the possible mechanism of acupuncture in the treatment of short-term insomnia from the perspective of hyperarousal mechanism by testing heart rate variability, serum cortisol and FIRST.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics and trial registration:\u003c/strong\u003e This protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine (Beijing TCM Hospital), the approval number is 2023BL02-103-02. It’s also been registered on ClinicalTrials.gov (URL: \u003ca href=\"https://clinicaltrials.gov/study/NCT06212934\"\u003ehttps://clinicaltrials.gov/study/NCT06212934\u003c/a\u003e).\u003c/p\u003e","manuscriptTitle":"A study of acupuncturing “Chou’s Tiaoshen” acupoints on short-term insomnia patients: study protocol for a randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-04-04 17:40:06","doi":"10.21203/rs.3.rs-4182329/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"70408a45-efdb-43e7-88f8-2167430f4f7e","owner":[],"postedDate":"April 4th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-04-23T15:00:55+00:00","versionOfRecord":[],"versionCreatedAt":"2024-04-04 17:40:06","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4182329","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4182329","identity":"rs-4182329","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}