The effectiveness and satefy of auricular acupoint therapy for patients with chronic insomnia: study protocol for a randomized controlled trial

AbstractBackground:Chronic insomnia (CI) is the most common subtype of insomnia. Auricular acupoint therapy (auricular acupoint bloodletting plus auricular acupressure) is a common treatment for CI, but its efficacy is uncertain due to the poor quality of previous studies. The purpose of this study is to evaluate the efficacy and safety of auricular acupoints in the treatment of CI by comparing with sham auricular acupoint therapy.Methods:This is a multicenter, randomized, two-arm interventional clinical trial. Participants will participate in the study for a total of 18 weeks, consisting of three phases: 2 weeks of screening, 4 weeks of treatment, and 12 weeks of follow-up. Based on the response rate of the primary outcome in our previous study, 156 randomly allocated participants are planned. Eligible participants will be randomly assigned to the auricular acupoint therapy group and sham auricular acupoint therapy group according to a ratio of 1:1. A total of 8 sessions in 4-week treatment period will be carried out. The primary outcome is a response rate at week 4, and the responder is defined as the percentage of those having at least 3 points reduction in insomnia symptoms from baseline as measured via the Pittsburgh Sleep Quality Index (PSQI). Furthermore, response rates at other weeks, PSQI, Insomnia Severity Index (ISI), Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), World Health Organization Quality of Life Scale-Abbreviated Form (WHOQOL-BREF), as well as sleep efficiency (SE), sleep arousal frequency (SA) and total sleep time (TST) recorded by actigraphy are chosen as secondary outcomes.Trial registration:www.chictr.org.cnIdentifer: ChiCTR2200065187, Registered 31 Oct 2022.