Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study.

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Sleep is therefore an important treatment target throughout the natural history of dementia and there is increasing interest in sleep as a modifiable risk factor. Clinical trials of interventions to improve sleep in people with cognitive impairment are beset by wide heterogeneity in the outcome measures reported. A core outcome set (COS) is urgently required to improve the coherence and comparability of data. Aim To produce a COS for clinical trials of interventions to improve sleep in people with cognitive impairment: the Sleep in Cognitive Impairment Core Outcome Set (SCICOS). Methods The Core Outcome Set-STAndards for Development: the COS-STAD recommendations will be followed. A systematic review (Registration: CRD42024556750) will identify outcome measures used in relevant clinical trials. Qualitative interviews involving people living with cognitive impairment and their caregivers will ascertain the outcome measures important to them. Finally, a modified Delphi process, involving people living with cognitive impairment and their caregivers as well as expert clinicians and researchers, will be conducted to reach consensus regarding the final composition of the SCICOS. Conclusion Interventions to improve sleep in people with cognitive impairment may reduce distress associated with sleep disturbance and, potentially, slow progression of cognitive decline. Creating the SCICOS will facilitate development of more meaningful and coherent data to drive progress in this emerging field. " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://hrbopenresearch.org/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://hrbopenresearch.org/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://hrbopenresearch.org/articles/7-67/v3", "name": "Protocol for the creation of a core outcome set for clinical trials..." } } ] } Home Browse Protocol for the creation of a core outcome set for clinical trials... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Crowley P, Flanagan E and O'Caoimh R. Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.12688/hrbopenres.14004.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Revised Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] Patrick Crowley https://orcid.org/0009-0008-9767-5907 1,2 , Evelyn Flanagan 1,2 , Rónán O'Caoimh https://orcid.org/0000-0002-1499-673X 1 Patrick Crowley https://orcid.org/0009-0008-9767-5907 1,2 , Evelyn Flanagan 1,2 , Rónán O'Caoimh https://orcid.org/0000-0002-1499-673X 1 PUBLISHED 09 Jan 2026 Author details Author details 1 Mercy University Hospital, Cork, County Cork, T12 WE28, Ireland 2 University College Cork, Cork, County Cork, Ireland Patrick Crowley Roles: Conceptualization, Funding Acquisition, Project Administration, Writing – Original Draft Preparation Evelyn Flanagan Roles: Funding Acquisition, Writing – Review & Editing Rónán O'Caoimh Roles: Conceptualization, Funding Acquisition, Project Administration, Supervision, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Background While sleep disturbance is common in dementia, leading to negative outcomes, there is growing evidence that sleep disturbance begins early in prodromal dementia and may contribute to cognitive decline. Sleep is therefore an important treatment target throughout the natural history of dementia and there is increasing interest in sleep as a modifiable risk factor. Clinical trials of interventions to improve sleep in people with cognitive impairment are beset by wide heterogeneity in the outcome measures reported. A core outcome set (COS) is urgently required to improve the coherence and comparability of data. Aim To produce a COS for clinical trials of interventions to improve sleep in people with cognitive impairment: the Sleep in Cognitive Impairment Core Outcome Set (SCICOS). Methods The Core Outcome Set-STAndards for Development: the COS-STAD recommendations will be followed. A systematic review (Registration: CRD42024556750) will identify outcome measures used in relevant clinical trials. Qualitative interviews involving people living with cognitive impairment and their caregivers will ascertain the outcome measures important to them. Finally, a modified Delphi process, involving people living with cognitive impairment and their caregivers as well as expert clinicians and researchers, will be conducted to reach consensus regarding the final composition of the SCICOS. Conclusion Interventions to improve sleep in people with cognitive impairment may reduce distress associated with sleep disturbance and, potentially, slow progression of cognitive decline. Creating the SCICOS will facilitate development of more meaningful and coherent data to drive progress in this emerging field. READ ALL READ LESS Keywords Sleep. Dementia. Mild cognitive impairment. Core Outcome Set. Protocol. Corresponding Author(s) Patrick Crowley ( [email protected] ) Close Corresponding author: Patrick Crowley Competing interests: No competing interests were disclosed. Grant information: Health Research Board [HRB DTICTN-2021-003]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2026 Crowley P et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Crowley P, Flanagan E and O'Caoimh R. Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.12688/hrbopenres.14004.3 ) First published: 28 Oct 2024, 7 :67 ( https://doi.org/10.12688/hrbopenres.14004.1 ) Latest published: 09 Jan 2026, 7 :67 ( https://doi.org/10.12688/hrbopenres.14004.3 ) Revised Amendments from Version 2 In the Methods section, minor changes are made to the paragraph that is sub-headed “Step 1: A systematic review” in order to emphasise more clearly that a detailed protocol for the systematic review has been published elsewhere. Further details regarding the methodology to be employed in the systematic review are available in said protocol. In the Methods section, the paragraph that is sub-headed “Step 2: Qualitative semi-structured interviews” has been amended to provide some further clarification regarding the eligibility criteria for participation in said interviews. It is clarified that participants will have both cognitive impairment and co-morbid sleep disturbance. Further detail is provided regarding the manner in which the severity of participants’ cognitive impairment will be determined and described. Finally, a sentence is added to explain that, while there may be some concern regarding the ability of people with cognitive impairment to participate reliably in such interviews, it is their own subjective experience and insights that are important to inform the design of the core outcome set. In the Methods section, minor changes are made to the paragraph that is sub-headed “Step 1: A systematic review” in order to emphasise more clearly that a detailed protocol for the systematic review has been published elsewhere. Further details regarding the methodology to be employed in the systematic review are available in said protocol. In the Methods section, the paragraph that is sub-headed “Step 2: Qualitative semi-structured interviews” has been amended to provide some further clarification regarding the eligibility criteria for participation in said interviews. It is clarified that participants will have both cognitive impairment and co-morbid sleep disturbance. Further detail is provided regarding the manner in which the severity of participants’ cognitive impairment will be determined and described. Finally, a sentence is added to explain that, while there may be some concern regarding the ability of people with cognitive impairment to participate reliably in such interviews, it is their own subjective experience and insights that are important to inform the design of the core outcome set. See the authors' detailed response to the review by Maria Basta READ REVIEWER RESPONSES Introduction There are approximately 55 million people living with dementia worldwide and, with a rapidly growing and ageing population, the global prevalence of dementia is expected to increase to 139 million by 2050 1 . Despite the recent emergence of disease-modifying therapies 2 – 4 , there is no curative treatment. Clinical management, therefore, remains largely focused on addressing modifiable risk factors to prevent development and progression of prodromal dementia, and on reducing the symptom burden in more advanced cases. Sleep disturbance affects up to 70% of people with cognitive impairment 5 and contributes to worsening cognitive outcomes 5 , impaired daytime functioning and deteriorating quality of life 6 . The increased carer burden caused by sleep disturbance in people with dementia has been shown to lead to sub-optimal care 7 and early institutionalisation 8 , which increases the economic burden of dementia care 9 . There is also increasing evidence that sleep disturbance may play a role in precipitating the onset and accelerating the progression of cognitive decline 10 . At a biological level, for example, there is evidence that sleep disturbance may increase accumulation within the cerebrospinal fluid of the beta-amyloid and tau proteins that are biomarkers of Alzheimer’s disease 11 . Although the recently published Dementia Prevention, Intervention and Care: 2024 report of the Lancet Commission 12 has reaffirmed that additional research is required to definitively clarify the effect of sleep on cognitive decline, interest is nevertheless growing in sleep as a modifiable risk factor for cognitive impairment 13 . Despite the importance of sleep as a treatment target throughout the natural history of dementia, to potentially slow disease progression in prodromal stages and to reduce the burden of symptoms in more advanced cases, the evidence base supporting clinical practice is limited 14 . One review notably concluded that “the literature available to guide effective treatment of sleep in patients with Alzheimer’s disease is woefully insufficient” 6 . Systematic reviews of interventions to improve sleep in people with cognitive impairment have been limited by small sample sizes with wide heterogeneity, both in the manner in which sleep is measured and in the outcome measures reported, limiting data synthesis 15 , 16 . A 2022 scoping review of the measurement of sleep in people with mild cognitive impairment (MCI) and mild dementia found that, after synonymous terms had been combined, 165 separate sleep outcomes were reported across all included studies 17 . This heterogeneity limits comparability of data, which precludes data synthesis and inhibits the development of a robust evidence base to guide clinical practice. Furthermore, 62 (37.6%) of the 165 sleep-related outcomes were reported in only one included study, raising the possibility of positive-finding publication bias. In addition to this heterogeneity in the outcome measures reported, the aforementioned scoping review 17 demonstrated significant variability in the methods used to measure sleep. Of the 188 studies included in the review, 131 used subjective measures of sleep such as questionnaires or sleep diaries. Objective measures of sleep were used less frequently, with polysomnography being used in 88 and medical-grade actigraphy being used in 37 of the included studies. It is, perhaps, unsurprising that most of the studies used subjective measures of sleep, given their low cost, ease of administration and the relatively low burden imposed on participants 17A . However, discrepancies between subjective and objective measures of sleep in people with cognitive impairment are well documented 17B – 17C . While the subjective experience of sleep is an important outcome measure in its own right, subjective measures of sleep are undoubtedly susceptible to recall bias, which is likely to be particularly problematic among people with cognitive impairment 17D . Polysomnography is widely recognised as the gold standard method of measuring sleep 17E . However, it is relatively expensive, requires expertise for interpretation, and the more invasive nature of the assessment – generally requiring overnight stays in sleep laboratories whilst wearing multiple attachments to measurement equipment – may be unsuitable for people with more advanced cognitive impairment 17D . There are several other methods of measuring sleep objectively, each with its own associated advantages and disadvantages 17F and varying degrees of accuracy compared to gold standard polysomnography 17G . Acknowledging that there is no direct one-to-one relation between the different methods of measuring sleep, subjective and objective measures likely make their own uniquely valuable contributions to sleep quantification 17H . The lack of concordance between them, however, further limits opportunities to compare data from clinical trials that use different methods of measuring sleep. A core outcome set (COS) is therefore urgently required to improve the coherence and utility of research data in the field. A COS is an agreed standard or minimum set of measurements and outcomes that all studies in a particular field of research are recommended to report 18 . This study aims to involve key stakeholders, including people living with cognitive impairment and their caregivers, in the creation of a COS for clinical trials of interventions to improve sleep in people with cognitive impairment – the Sleep in Cognitive Impairment Core Outcome Set (SCICOS). The SCICOS will increase clinical trial efficiency, reduce the risk of reporting bias, improve data synthesis and help build a robust evidence base for interventions that improve the lives of people living with cognitive impairment and their caregivers. Methods The SCICOS has been registered on the Core Outcome Measures in Effectiveness Trials (COMET) database (see: https://www.comet-initiative.org/Studies/Details/3250 ) and will be created in accordance with the Core Outcome Set - STAndards for Development (COS-STAD) recommendations from the COMET Initiative 19 . These recommendations will, however, be adapted to facilitate participation of people living with cognitive impairment and their caregivers, as suggested by the CO-research Involvement and Engagement in Dementia (COINED) model 20 . The SCICOS study design will therefore involve a multi-stage mixed methods approach in four steps, as follows (see Figure 1 ): Figure 1. Flowchart of the SCICOS study design. SCICOS = Sleep in Cognitive Impairment Core Outcome Set . Step 1: A systematic review will be undertaken of randomised and non-randomised controlled clinical trials involving both pharmacological and non-pharmacological interventions to improve sleep in people with cognitive impairment, encompassing those with MCI and dementia. A detailed protocol for the systematic review has been published elsewhere 21 and has been registered with the International Prospective Register of Systematic Reviews (PROSPERO), registration number: CRD42024556750. The systematic review will produce a list of all the outcome measures reported in the included trials. Step 2: Qualitative semi-structured interviews will be conducted among a convenience sample of 20 – 25 people living with cognitive impairment and co-morbid sleep disturbance, and/or their caregivers, to examine what matters most to them when determining the effectiveness of an intervention to improve sleep. The interviews will therefore endeavour to ascertain the outcome measures that people living with cognitive impairment and their caregivers deem most important in any clinical trial of an intervention designed to improve sleep. Purposive sampling will be used to include people living with different stages of cognitive impairment 21A , as determined by a consultant physician in geriatric medicine. In this regard, the Reisberg FAST criteria will be used to describe the severity of participants’ cognitive impairment 21B . While there may be some concern regarding the ability of people with cognitive impairment to participate reliably in these interviews, it is nevertheless their own subjective experience and insights that are sought. When developing a core outcome set, it is important to garner the opinions of people with lived experience of the medical condition being examined in this manner, as they may indicate additional outcomes of importance or emphasise different priorities compared to those suggested by clinicians or researchers 22 . Participants will be drawn from patients and, if required, their caregivers attending memory clinics at the Mercy University Hospital in Cork, Ireland. They will also be drawn from the Patient and Public Involvement (PPI) panels of Dementia Trials Ireland (DTI), a Clinical Trials Network funded by the Health Research Board of Ireland. Prior informed written consent will be obtained from all participants. A bespoke interview topic guide will be used (see Table 1 in extended data). Responses will be recorded and transcribed verbatim. Qualitative data analysis software will be used to analyse the transcripts in accordance with the reflexive thematic analysis approach espoused by Braun and Clarke 23 . Step 3: Collating the results of the systematic review and the qualitative semi-structured interviews. Any additional outcome measures suggested by the qualitative semi-structured interviews (described in step 2 above) will be collated with the list of outcome measures produced by the systematic review (described in step 1 above) to produce a preliminary ‘long list’ of outcome measures. These initial outcome measures will be categorised by domain and core area in accordance with the OMERACT Filter 2.0 Framework 24 . Outcome measures within the same domain that are synonymous or similar may be combined to avoid unnecessary duplication. The categorisation and combination of outcome measures in this manner will be undertaken independently by two researchers and any disagreements will be resolved by the principal investigator, as recommended by the COMET Handbook 25 . A previous scoping review examining studies involving the measurement of sleep in people with MCI and mild dementia has demonstrated that many outcome measures appear in only one (37.6%) or two (58.8%) studies 17 . As any outcome measure that appears so infrequently is unlikely to be considered a core outcome measure, we will exclude from further consideration in the modified Delphi process any outcome measure that: (a) appears in only one clinical trial, or (b) appears in any number of clinical trials which, when combined, involve less than 1% of the total number of participants involved in all the clinical trials included in the planned systematic review, described above. Step 4: A modified Delphi process will be employed to reach consensus regarding the outcome measures that should be included in the SCICOS 25 . There is no consensus on the recommended sample size for a Delphi panel 25 . We aim to include sufficient lay and professional participants to ensure comprehensive representation of different perspectives at all stages of the process 25 . Different modes of participation in the modified Delphi process will be offered to professional and lay participants in order to facilitate involvement of people living with cognitive impairment and their caregivers 26 . Fully informed prior written consent to participation will be obtained from all participants. Demographic details, including age, sex and stakeholder group (either professional or lay participants) will be collected. Professional participants Professional participants will have an established research interest in sleep and/or dementia. They will be drawn primarily from among the authors of research papers that are included in the systematic review mentioned in step 1 above. Professional participants will be invited to participate in the modified Delphi process by completing an electronic survey administered via an online platform. Lay participants Lay participants will be people living with cognitive impairment or their caregivers. They will be drawn from the PPI panel of DTI and from patients attending memory clinics at the Mercy University Hospital in Cork, Ireland. To facilitate meaningful involvement of people living with cognitive impairment and their caregivers in the modified Delphi process, lay participants will be offered different modes of completing the Delphi surveys 26 . Lay participants may complete the Delphi surveys via paper-based survey and may avail of the assistance of a researcher to do so via a researcher-supported survey. A researcher-supported survey involves a researcher supporting the participation of the person living with cognitive impairment by helping them to complete the survey 26 . Delphi surveys and consensus process The modified Delphi process will consist of two ‘rounds’ of surveys, in which participants are asked to rate the importance of each outcome measure, before a final consensus meeting is convened among a sub-set of participants to determine which outcome measures will be included in the SCICOS. In line with the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) 27 , professional participants will be asked to score the importance of each outcome measure on a 9-point Likert scale 28 . Subsequently, in order to align with the scores of lay participants (see below), scores from 1 to 3 will be defined as ‘not particularly important’, scores from 4 to 6 will be defined as ‘important but not critical’ and scores from 7 to 9 will be defined as ‘very important’. Each outcome measure included in the lay participants’ Delphi survey will be accompanied by an ‘accessible statement’, which is a simple, clear and concise description of the outcome measure in plain non-technical language 29 . The Likert scale will also be adapted in the lay participants’ Delphi survey 25 . Previous research has demonstrated that Likert-scales with five or more points are unsuccessful in people with dementia 30 . Instead, therefore, a three-point scale will be used: ‘not particularly important’, ‘important but not critical’, and ‘very important’ 26 . The following criteria will be applied in order to determine which outcome measures qualify for consideration at the final consensus meeting. In each of the two rounds of Delphi surveys, outcome measures will qualify for consideration at the final consensus meeting if at least 70% of all participants regard them as ‘very important’ and less than 15% regard them as ‘not particularly important’, or if over 90% of participants from one stakeholder group regard them as ‘very important’ 31 . After the first Delphi survey round, outcome measures will be excluded from further consideration in the second round if at least 70% of all participants regard them as ‘not particularly important’ and less than 15% regard them as ‘very important’. During the second Delphi survey round, the results of the first round will be available to participants for consideration and they will be asked if they would like to change how they rated each remaining outcome measure in light of this information. Consensus meeting Following the second Delphi survey round, the final consensus meeting will be convened virtually to determine the ultimate composition of the SCICOS. All participants in the two Delphi survey rounds will be invited to participate in the final consensus meeting. Outcome measures will be considered at the final consensus meeting if, in either of the two preceding Delphi survey rounds, at least 70% of all participants rated them as ‘very important’ and less than 15% rated them as ‘not particularly important’, or if over 90% of participants from one stakeholder group regarded them as ‘very important’ 31 . At the final consensus meeting, each such outcome measure will be considered in turn and will be included in the SCICOS if at least 70% of participants, including at least one person from each stakeholder group, votes in favour of its inclusion in the SCICOS. Additionally, participants will be invited to give their opinion regarding the most appropriate method of measuring each outcome measure that is included in the SCICOS. In this way, the SCICOS will not only prescribe a core set of outcome measures for clinical trials of interventions to improve sleep in people with cognitive impairment, but will also make recommendations regarding the most appropriate method of measuring those outcome measures. This will help to reduce problems associated with the lack of concordance between the different methods of measuring sleep. Study status The study has commenced and is currently on-going. Discussion In recent years, due to the growing burden of dementia 1 and an increasing preponderance of evidence implicating sleep disturbance not just in its symptomatology but also perhaps in its pathophysiology 10 , 11 , there is growing research interest in the treatment of sleep disturbance in people with cognitive impairment 13 , 17 . Most clinical trials of interventions to improve sleep in people with cognitive impairment have been limited by small sample sizes 15 , 16 . The synthesis of data from these trials has been limited in turn by wide heterogeneity both in the methods used to measure sleep and in the outcome measures reported, precluding meta-analysis 16 and impeding the development of a reliable evidence base to guide clinical practice. Given the challenges inherent in conducting clinical research among people with cognitive impairment 32 , it is important to ensure that future research is reliable and coherent, thus increasing the likelihood that the research will lead to clinically meaningful insights. The SCICOS will improve the utility and efficiency of future clinical trials by prescribing a standard minimum set of outcome measures, and making recommendations regarding the methods used to measure them, thus reducing risk of reporting bias and facilitating meta-analysis. The SCICOS will be developed in accordance with the COS-STAD recommendations 19 . Clinicians and researchers from around the world with established expertise in sleep and/or dementia will be invited to participate to optimise generalisability, credibility and relevance. The COS-STAD recommendations will be adapted to ensure meaningful involvement of people living with cognitive impairment and their caregivers throughout the process of developing the SCICOS. A 2020 Cochrane review of pharmacotherapies in dementia 33 found that clinical trials do not always succeed in taking account of what matters most to the end-users of the tested interventions. In ancillary qualitative research among caregivers of people with dementia, it was noted that their highest priority outcome was uninterrupted sleep at night yet this was not included as an outcome measure in any of the included trials. The process for developing the SCICOS includes people living with cognitive impairment and their caregivers as key stakeholders. As a practical consequence of the adaptations made to the study design to facilitate meaningful involvement of people living with cognitive impairment and their caregivers, data collection from this key stakeholder group will be limited to Ireland. This may potentially introduce bias, as the level of importance attributed to outcome measures may vary across different countries and cultures. Nevertheless, by involving people living with cognitive impairment and their caregivers throughout the process of creating the SCICOS, this study will ensure that the voices of this key stakeholder group will be heard in all relevant future clinical trials. Conclusion There is growing interest in sleep disturbance as a modifiable risk factor for cognitive impairment. Sleep disturbance remains an important treatment target in more advanced dementia to alleviate the associated symptom burden and carer strain. Existing literature regarding the role of sleep in cognitive impairment is beset by wide heterogeneity in the methods used to measure sleep and in the outcome measures reported. Creating a COS for clinical trials involving interventions to improve sleep in people with cognitive impairment will increase comparability of data and help build the evidence base for interventions that can improve the lives of people living with cognitive impairment and their caregivers. Ethics and consent The SCICOS study will be conducted in accordance with the Declaration of Helsinki and General Data Protection Regulations (GDPR). Ethical approval was granted for each phase of this study by the Clinical Research Ethics Committee of the Cork Teaching Hospitals (CREC) on 30 th July 2024, reference numbers: ECM 4 (c) 06/02/2024 & ECM 5 (7) 20/02/2024 & ECM 4 (dd) 30/07/2024. Fully informed written consent will be obtained from all participants prior to their participation in the study. In order to facilitate the process of obtaining fully informed consent, each prospective participant will be provided with a comprehensive Participant Information Leaflet that is appropriate to their personal circumstances. Separate versions of the Participant Information Leaflet will be provided to prospective participants from each stakeholder group, namely professional and lay participants. Within the latter stakeholder group, separate versions of the Participant Information Leaflet will be provided to people living with cognitive impairment and their caregivers. Copies of each version of the Participant Information Leaflet and Consent Form are provided in the extended data. Dissemination The SCICOS will be reported in accordance with the Core Outcome Set-STAndards for Reporting: the COS-STAR Statement 34 . Everybody who participated in the process of developing the SCICOS will be provided with a copy of the final report. The SCICOS will be disseminated through submission for publication in a peer reviewed medical journal and promulgation at relevant clinical conferences. Data availability statement Underlying data No data are associated with this article. Extended data Open Science Framework: Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. https://doi.org/10.17605/OSF.IO/U96RJ This article contains the following extended data 35 : Lay (Patient) Participant Information Leaflet & Consent Form Lay (Carer) Participant Information Leaflet & Consent Form Professional Participant Information Leaflet & Consent Form Table 1. (Qualitative Interview Topic Guide) Reporting guidelines Open Science Framework: Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. https://doi.org/10.17605/OSF.IO/U96RJ This article contains the following reporting guidelines 35 : Completed PRISMA-P Checklist Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 universal). Faculty Opinions recommended References 1. World Health Organisation: World failing to address dementia challenge. Geneva: World Health Organisation, 2021; [updated September 2nd 2021; cited September 13th 2024]. Reference Source 2. Food and Drug Administration: FDA grants accelerated approval for Alzheimer’s drug. Silver Spring, Maryland: Food and Drug Administration, 2021; [updated June 7th 2021; cited September 13th 2024]. 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Crowley P, Flanagan E, O’Caoimh R: Protocol for the creation of a Core Outcome Set for clinical trials of interventions to improve sleep in people with cognitive impairment: the Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. 2024. http://www.doi.org/10.17605/OSF.IO/U96RJ Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 28 Oct 2024 ADD YOUR COMMENT Comment Author details Author details 1 Mercy University Hospital, Cork, County Cork, T12 WE28, Ireland 2 University College Cork, Cork, County Cork, Ireland Patrick Crowley Roles: Conceptualization, Funding Acquisition, Project Administration, Writing – Original Draft Preparation Evelyn Flanagan Roles: Funding Acquisition, Writing – Review & Editing Rónán O'Caoimh Roles: Conceptualization, Funding Acquisition, Project Administration, Supervision, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information Health Research Board [HRB DTICTN-2021-003]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (3) version 3 Revised Published: 09 Jan 2026, 7:67 https://doi.org/10.12688/hrbopenres.14004.3 version 2 Revised Published: 06 May 2025, 7:67 https://doi.org/10.12688/hrbopenres.14004.2 version 1 Published: 28 Oct 2024, 7:67 https://doi.org/10.12688/hrbopenres.14004.1 Copyright © 2026 Crowley P et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics VIEWS $counts.viewCount downloads Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Crowley P, Flanagan E and O'Caoimh R. Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.12688/hrbopenres.14004.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 2 VERSION 2 PUBLISHED 06 May 2025 Revised Views 0 Cite How to cite this report: Basta M. Reviewer Report For: Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.21956/hrbopenres.15552.r47555 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-67/v2#referee-response-47555 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 25 Aug 2025 Maria Basta , Technical University of Crete, Chania, Crete Region, Greece Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15552.r47555 The role of sleep as a potential modifiable factor that could reverse of delay the course of cognitive decline among people with cognitive deficits has drawn the attention of numerous research studies during the last decades. Indeed, as authors emphasize, ... Continue reading READ ALL The role of sleep as a potential modifiable factor that could reverse of delay the course of cognitive decline among people with cognitive deficits has drawn the attention of numerous research studies during the last decades. Indeed, as authors emphasize, studies on topics are heterogeneous based on different methodological approaches, measuring different sleep characteristics (i.e. duration, quality, subjective vs. objective parameters), different disease severity, coming from different settings (i.e. community-based vs. institutionalized populations). Therefore establishing a Core Outcome Set (COS) of sleep parameters would improve the coherence and comparability of data. This protocol aims to produce a COS for clinical trials of interventions to improve sleep with Sleep Cognitive Impairment (i.e. MCI and dementia) COS (SCICOS). Authors do report information about the methods used, however more details should be provided to allow replication by others. For example, more information should be provided about the methodology they are planning to follow for the systematic review. Given that the article by Blackman et al does not include all existing literature (for example studies from the Cretan Aging Cohort and HELIAD study are not included), authors should describe a more thorough procedure that would included all up to date associated studies. Additionally, regarding the qualitative interviews authors should clarify the inclusion criteria of the people living with cognitive impairment, taking under consideration that their cognitive function should be adequate to provide reliable answers. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: sleep medicine , geriatric psychiatry I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Basta M. Reviewer Report For: Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.21956/hrbopenres.15552.r47555 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-67/v2#referee-response-47555 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 09 Jan 2026 Patrick Crowley , Mercy University Hospital, Cork, T12 WE28, Ireland 09 Jan 2026 Author Response Thank you for your thoughtful review and for acknowledging the rationale for developing this core outcome set. In the Methods section, we have edited the paragraph that is sub-headed ... Continue reading Thank you for your thoughtful review and for acknowledging the rationale for developing this core outcome set. In the Methods section, we have edited the paragraph that is sub-headed “Step 1: A systematic review” in order to emphasise more clearly that a detailed protocol for the systematic review has been published elsewhere. Further details regarding the methodology to be employed in the systematic review are available in said protocol. Later in the Methods section, the paragraph that is sub-headed “Step 2: Qualitative semi-structured interviews” has been amended to provide some further clarification regarding the eligibility criteria for participation in said interviews. It is clarified that participants will have both cognitive impairment and co-morbid sleep disturbance. Further detail is provided regarding the manner in which the severity of participants’ cognitive impairment will be determined and described. While there may be some concern regarding the ability of people with cognitive impairment to participate reliably in such interviews, it is nevertheless their own subjective experience and insights that are important to inform the design of the core outcome set. It is important to garner the opinions of people with lived experience of the medical condition being examined in this manner, as they may indicate additional outcomes of importance or emphasise different priorities compared to those suggested by clinicians or researchers. Thank you for your thoughtful review and for acknowledging the rationale for developing this core outcome set. In the Methods section, we have edited the paragraph that is sub-headed “Step 1: A systematic review” in order to emphasise more clearly that a detailed protocol for the systematic review has been published elsewhere. Further details regarding the methodology to be employed in the systematic review are available in said protocol. Later in the Methods section, the paragraph that is sub-headed “Step 2: Qualitative semi-structured interviews” has been amended to provide some further clarification regarding the eligibility criteria for participation in said interviews. It is clarified that participants will have both cognitive impairment and co-morbid sleep disturbance. Further detail is provided regarding the manner in which the severity of participants’ cognitive impairment will be determined and described. While there may be some concern regarding the ability of people with cognitive impairment to participate reliably in such interviews, it is nevertheless their own subjective experience and insights that are important to inform the design of the core outcome set. It is important to garner the opinions of people with lived experience of the medical condition being examined in this manner, as they may indicate additional outcomes of importance or emphasise different priorities compared to those suggested by clinicians or researchers. Competing Interests: No competing interests to declare. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 09 Jan 2026 Patrick Crowley , Mercy University Hospital, Cork, T12 WE28, Ireland 09 Jan 2026 Author Response Thank you for your thoughtful review and for acknowledging the rationale for developing this core outcome set. In the Methods section, we have edited the paragraph that is sub-headed ... Continue reading Thank you for your thoughtful review and for acknowledging the rationale for developing this core outcome set. In the Methods section, we have edited the paragraph that is sub-headed “Step 1: A systematic review” in order to emphasise more clearly that a detailed protocol for the systematic review has been published elsewhere. Further details regarding the methodology to be employed in the systematic review are available in said protocol. Later in the Methods section, the paragraph that is sub-headed “Step 2: Qualitative semi-structured interviews” has been amended to provide some further clarification regarding the eligibility criteria for participation in said interviews. It is clarified that participants will have both cognitive impairment and co-morbid sleep disturbance. Further detail is provided regarding the manner in which the severity of participants’ cognitive impairment will be determined and described. While there may be some concern regarding the ability of people with cognitive impairment to participate reliably in such interviews, it is nevertheless their own subjective experience and insights that are important to inform the design of the core outcome set. It is important to garner the opinions of people with lived experience of the medical condition being examined in this manner, as they may indicate additional outcomes of importance or emphasise different priorities compared to those suggested by clinicians or researchers. Thank you for your thoughtful review and for acknowledging the rationale for developing this core outcome set. In the Methods section, we have edited the paragraph that is sub-headed “Step 1: A systematic review” in order to emphasise more clearly that a detailed protocol for the systematic review has been published elsewhere. Further details regarding the methodology to be employed in the systematic review are available in said protocol. Later in the Methods section, the paragraph that is sub-headed “Step 2: Qualitative semi-structured interviews” has been amended to provide some further clarification regarding the eligibility criteria for participation in said interviews. It is clarified that participants will have both cognitive impairment and co-morbid sleep disturbance. Further detail is provided regarding the manner in which the severity of participants’ cognitive impairment will be determined and described. While there may be some concern regarding the ability of people with cognitive impairment to participate reliably in such interviews, it is nevertheless their own subjective experience and insights that are important to inform the design of the core outcome set. It is important to garner the opinions of people with lived experience of the medical condition being examined in this manner, as they may indicate additional outcomes of importance or emphasise different priorities compared to those suggested by clinicians or researchers. Competing Interests: No competing interests to declare. Close Report a concern COMMENT ON THIS REPORT Version 1 VERSION 1 PUBLISHED 28 Oct 2024 Views 0 Cite How to cite this report: Lazar AS. Reviewer Report For: Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.21956/hrbopenres.15370.r44048 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-67/v1#referee-response-44048 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 07 Jan 2025 Alpar S Lazar , University of East Anglia, Norwich, England, UK Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15370.r44048 The role of sleep duration and quality in age-dependent cognitive decline, neurodegeneration, and quality of life is undoubtedly critical, driving extensive research in the field. However, as the authors rightly highlight, there is significant heterogeneity in how sleep is measured ... Continue reading READ ALL The role of sleep duration and quality in age-dependent cognitive decline, neurodegeneration, and quality of life is undoubtedly critical, driving extensive research in the field. However, as the authors rightly highlight, there is significant heterogeneity in how sleep is measured and reported across clinical trials. This variability makes it challenging to compare and interpret results across different clinical studies. Given that age-dependent cognitive decline is a growing public health concern, such methodological shortcomings in the field may impede the development of effective interventions aimed at improving sleep quality to positively influence cognitive aging and enhance quality of life. To address this issue, the authors propose the development of a standardized set of sleep outcomes to be used in clinical sleep studies focused on cognitive impairment ( Sleep in Cognitive Impairment Core Outcome Set, SCICOS) , following established methodologies. The planned methods for this initiative, including a systematic review and the integration of both quantitative and qualitative research approaches, are a clear strength of the proposal. The inclusion of input from both professionals and individuals with lived experiences (patients and caregivers) enhances the relevance and applicability of the proposed SCICOS. However, the proposal could benefit from a more extensive discussion of the two major methodological approaches to sleep assessment: subjective and objective measurements. Both approaches offer distinct advantages and limitations, and a frequently observed challenge in sleep research is the lack of concordance between them, despite their critical role as outcome measures. In the realm of objective sleep assessment, a wide variety of tools are available, ranging from the gold-standard polysomnography to wearable and contactless devices. These methods differ significantly in feasibility, accuracy, and their ability to identify sleep problems. The suitability of each tool often depends on the specific aims of the study, the characteristics of the population being studied, and the resources available. Addressing these issues more comprehensively within the proposal would strengthen its practical relevance. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: I am a sleep researcher with a focus on the role of sleep and biological rhythms in brain health I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Lazar AS. Reviewer Report For: Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.21956/hrbopenres.15370.r44048 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-67/v1#referee-response-44048 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Song M. Reviewer Report For: Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.21956/hrbopenres.15370.r43222 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-67/v1#referee-response-43222 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 02 Dec 2024 Min Song , China Pharmaceutical University, Nanjing, Jiangsu, China Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15370.r43222 The relationship between sleep disturbances and memory decline and cognitive impairment has attracted increasing attention. However, the lack of extensive and reliable clinical data has hindered the development of research in this area. The aim of this study is to ... Continue reading READ ALL The relationship between sleep disturbances and memory decline and cognitive impairment has attracted increasing attention. However, the lack of extensive and reliable clinical data has hindered the development of research in this area. The aim of this study is to develop a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment, specifically the Sleep in Cognitive Impairment Core Outcome Set, which is of practical significance. However, the use of qualitative semi-structured interviews is open to discussion. Descriptions from both patients and caregivers are inherently subjective. It may be worth considering more objective methods, such as monitoring sleep data and measuring biomarkers, while also recording the types of sleep interventions used and analyzing their correlations. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Alzheimer's disease and pharmaceutical analysis I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Song M. Reviewer Report For: Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.21956/hrbopenres.15370.r43222 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-67/v1#referee-response-43222 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 28 Oct 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 3 Version 3 (revision) 09 Jan 26 Version 2 (revision) 06 May 25 read Version 1 28 Oct 24 read read Min Song , China Pharmaceutical University, Nanjing, China Alpar S Lazar , University of East Anglia, Norwich, UK Maria Basta , Technical University of Crete, Chania, Greece Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Basta M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 25 Aug 2025 | for Version 2 Maria Basta , Technical University of Crete, Chania, Crete Region, Greece 0 Views copyright © 2025 Basta M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The role of sleep as a potential modifiable factor that could reverse of delay the course of cognitive decline among people with cognitive deficits has drawn the attention of numerous research studies during the last decades. Indeed, as authors emphasize, studies on topics are heterogeneous based on different methodological approaches, measuring different sleep characteristics (i.e. duration, quality, subjective vs. objective parameters), different disease severity, coming from different settings (i.e. community-based vs. institutionalized populations). Therefore establishing a Core Outcome Set (COS) of sleep parameters would improve the coherence and comparability of data. This protocol aims to produce a COS for clinical trials of interventions to improve sleep with Sleep Cognitive Impairment (i.e. MCI and dementia) COS (SCICOS). Authors do report information about the methods used, however more details should be provided to allow replication by others. For example, more information should be provided about the methodology they are planning to follow for the systematic review. Given that the article by Blackman et al does not include all existing literature (for example studies from the Cretan Aging Cohort and HELIAD study are not included), authors should describe a more thorough procedure that would included all up to date associated studies. Additionally, regarding the qualitative interviews authors should clarify the inclusion criteria of the people living with cognitive impairment, taking under consideration that their cognitive function should be adequate to provide reliable answers. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise sleep medicine , geriatric psychiatry I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 09 Jan 2026 Patrick Crowley, Mercy University Hospital, Cork, T12 WE28, Ireland Thank you for your thoughtful review and for acknowledging the rationale for developing this core outcome set. In the Methods section, we have edited the paragraph that is sub-headed “Step 1: A systematic review” in order to emphasise more clearly that a detailed protocol for the systematic review has been published elsewhere. Further details regarding the methodology to be employed in the systematic review are available in said protocol. Later in the Methods section, the paragraph that is sub-headed “Step 2: Qualitative semi-structured interviews” has been amended to provide some further clarification regarding the eligibility criteria for participation in said interviews. It is clarified that participants will have both cognitive impairment and co-morbid sleep disturbance. Further detail is provided regarding the manner in which the severity of participants’ cognitive impairment will be determined and described. While there may be some concern regarding the ability of people with cognitive impairment to participate reliably in such interviews, it is nevertheless their own subjective experience and insights that are important to inform the design of the core outcome set. It is important to garner the opinions of people with lived experience of the medical condition being examined in this manner, as they may indicate additional outcomes of importance or emphasise different priorities compared to those suggested by clinicians or researchers. View more View less Competing Interests No competing interests to declare. reply Respond Report a concern Basta M. Peer Review Report For: Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.21956/hrbopenres.15552.r47555) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-67/v2#referee-response-47555 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Lazar A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 07 Jan 2025 | for Version 1 Alpar S Lazar , University of East Anglia, Norwich, England, UK 0 Views copyright © 2025 Lazar A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The role of sleep duration and quality in age-dependent cognitive decline, neurodegeneration, and quality of life is undoubtedly critical, driving extensive research in the field. However, as the authors rightly highlight, there is significant heterogeneity in how sleep is measured and reported across clinical trials. This variability makes it challenging to compare and interpret results across different clinical studies. Given that age-dependent cognitive decline is a growing public health concern, such methodological shortcomings in the field may impede the development of effective interventions aimed at improving sleep quality to positively influence cognitive aging and enhance quality of life. To address this issue, the authors propose the development of a standardized set of sleep outcomes to be used in clinical sleep studies focused on cognitive impairment ( Sleep in Cognitive Impairment Core Outcome Set, SCICOS) , following established methodologies. The planned methods for this initiative, including a systematic review and the integration of both quantitative and qualitative research approaches, are a clear strength of the proposal. The inclusion of input from both professionals and individuals with lived experiences (patients and caregivers) enhances the relevance and applicability of the proposed SCICOS. However, the proposal could benefit from a more extensive discussion of the two major methodological approaches to sleep assessment: subjective and objective measurements. Both approaches offer distinct advantages and limitations, and a frequently observed challenge in sleep research is the lack of concordance between them, despite their critical role as outcome measures. In the realm of objective sleep assessment, a wide variety of tools are available, ranging from the gold-standard polysomnography to wearable and contactless devices. These methods differ significantly in feasibility, accuracy, and their ability to identify sleep problems. The suitability of each tool often depends on the specific aims of the study, the characteristics of the population being studied, and the resources available. Addressing these issues more comprehensively within the proposal would strengthen its practical relevance. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise I am a sleep researcher with a focus on the role of sleep and biological rhythms in brain health I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Lazar AS. Peer Review Report For: Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.21956/hrbopenres.15370.r44048) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-67/v1#referee-response-44048 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Song M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 02 Dec 2024 | for Version 1 Min Song , China Pharmaceutical University, Nanjing, Jiangsu, China 0 Views copyright © 2024 Song M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The relationship between sleep disturbances and memory decline and cognitive impairment has attracted increasing attention. However, the lack of extensive and reliable clinical data has hindered the development of research in this area. The aim of this study is to develop a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment, specifically the Sleep in Cognitive Impairment Core Outcome Set, which is of practical significance. However, the use of qualitative semi-structured interviews is open to discussion. Descriptions from both patients and caregivers are inherently subjective. It may be worth considering more objective methods, such as monitoring sleep data and measuring biomarkers, while also recording the types of sleep interventions used and analyzing their correlations. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Alzheimer's disease and pharmaceutical analysis I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Song M. Peer Review Report For: Protocol for the creation of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment: The Sleep in Cognitive Impairment Core Outcome Set (SCICOS) study. [version 3; peer review: 3 approved with reservations] . HRB Open Res 2026, 7 :67 ( https://doi.org/10.21956/hrbopenres.15370.r43222) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-67/v1#referee-response-43222 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Adjust parameters to alter display View on desktop for interactive features Includes Interactive Elements View on desktop for interactive features Competing Interests Policy Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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