Perioperative sleep optimisation and brain health in older adults (SLEEP-BOOST): protocol for a randomised controlled trial.

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Learn more: PMC Disclaimer | PMC Copyright Notice BMJ Open . 2026 May 28;16(5):e116526. doi: 10.1136/bmjopen-2026-116526 Perioperative sleep optimisation and brain health in older adults (SLEEP-BOOST): protocol for a randomised controlled trial Anaëlle E Charles 1, 2, 0 , Andrea A Castillo Suárez 1, 2, 0 , Mansi Chhajed 1, 2 , Mili Jimenez Gallardo 1, 2 , Karoline Sanchez Valdes 1, 2 , Peng Li 1, 2, 3 , Kun Hu 1, 2, 3 , Patricia M Wong 4 , John Winkelman 5 , Lei Gao 1, 2, 3, ✉ Author information Article notes Copyright and License information 1 Anesthesia, Critical Care, and Pain Medicine | Perioperative Sleep and Brain Health Lab (PSBL), Massachusetts General Hospital, Boston, Massachusetts, USA 2 Anesthesia, Critical Care, and Pain Medicine | Medical Biodynamics Center (MBC), Massachusetts General Hospital, Boston, Massachusetts, USA 3 Division of Sleep Medicine, Harvard Medical School, Boston, Massachusetts, USA 4 Behavioral Sleep and Pain Medicine, Patricia Wong PhD LLC, Boston, Massachusetts, USA 5 Departments of Psychiatry and Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages) and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise. LG and PMW are spouses. PMW is the owner of Patricia Wong PhD LLC and served as a paid scientific consultant for the behavioural intervention design. The authors LG and PMW declare that this relationship was managed in accordance with institutional policy and did not bias the study design, data collection or analysis. ✉ Dr Lei Gao; lgao@mgh.harvard.edu 0 AEC and AACS are joint first authors. Received 2026 Jan 7; Accepted 2026 May 19; Collection date 2026. Copyright © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/ . PMC Copyright notice PMCID: PMC13223656  PMID: 42209013 Abstract Introduction Postoperative neurocognitive disorders, including delirium and longer-term cognitive decline, are among the most common and costly complications of surgery in older adults, yet effective preventive strategies remain limited. Insomnia and sleep–circadian disruption are highly prevalent in this population, affecting up to one-third of older adults undergoing elective surgery and represent potentially modifiable risk factors that are rarely addressed in perioperative care. Cognitive Behavioural Therapy for Insomnia (CBT-I) is the first-line, evidence-based treatment for insomnia; however, its feasibility and efficacy have not been systematically evaluated for perioperative implementation. This protocol describes a pilot randomised controlled trial designed to evaluate the feasibility and acceptability of a condensed CBT-I intervention in the perioperative setting. The study will also explore its potential effects on insomnia and postoperative outcomes. Methods The SLEEP-BOOST study is a single-site, randomised controlled pilot trial conducted at Massachusetts General Hospital. The study will enrol 50 older adults (≥65 years) undergoing elective orthopaedic surgery with insomnia symptoms (Insomnia Severity Index≥10). Participants will be randomised 1:1 to either a condensed CBT-I intervention or a patient contact-matched Sleep Hygiene Education control group. All participants will complete 3 weeks of preoperative actigraphy and daily sleep diaries, with follow-up assessments at 2 weeks, 1 month and 3 months after surgery. The primary outcome is feasibility, assessed through adherence metrics, protocol engagement and acceptability. Secondary outcomes will be treated as exploratory including insomnia severity, sleep quality, actigraphy-derived sleep and circadian metrics, cognitive trajectories, postoperative pain, mood, functional status and incidence of postoperative neurocognitive disorders. Ethics and dissemination This protocol has received ethics approval from Massachusetts General Hospital Institutional Review Board (Protocol #2024P000780). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant sleep treatment organisations. Participants will receive a summary of the study results. Trial registration number NCT06375265 . Keywords: Delirium, Aging, Insomnia, Cognition, Sleep medicine, SURGERY STRENGTHS AND LIMITATIONS OF THIS STUDY. The protocol uses a standardised, abbreviated CBT-I intervention delivered across five hybrid sessions before and after surgery. The hybrid delivery model (in-person or video-based sessions) supports feasibility within perioperative care settings. Participants with lower cognitive or technological proficiency may be less likely to complete the protocol, introducing potential selection bias. The inclusion of sleep hygiene education and regular contact in the control group may introduce a residual Hawthorne effect. Inclusion based on self-reported insomnia severity (ISI≥10) and identification of sleep apnoea via chart review and self-report may not fully capture objective sleep pathology. Introduction Sleep disorders, including insomnia, affect nearly one-third of older adults undergoing orthopaedic surgery, yet most cases remain untreated in perioperative care. 1 Growing evidence suggests that insomnia-related sleep disturbances greatly impede recovery, increasing vulnerability to develop postoperative neurocognitive disorders (PNDs). 2 PND encompasses acute cognitive disturbance (ie, delirium) after surgery and is the most prevalent postoperative complication in older adults, affecting up to half of individuals over the age of 65. 3 Once diagnosed, up to half can progress to Alzheimer’s disease (AD) and related dementias (ADRD) within 5 years. 2 Given the prevalence of older adults with untreated insomnia in perioperative care, 4 sleep interventions are urgently needed in an attempt to reduce postoperative cognitive decline and related complications. Insomnia is characterised by the difficulty of falling asleep, staying asleep, or both and contributes to the dysregulation of our 24 hours circadian rhythms (ie, internal clock) leading to a variety of health issues. Long-term consequences include cognitive dysfunction, 5 6 increased pain sensitivity/opioid use, 7 metabolic imbalance and immune function disruption. 8 9 Major surgery represents a physiological stressor that is particularly consequential for older adults. Our recent work showed that these poor sleep qualities and disrupted rhythms predicted cognitive decline, postoperative delirium and progression to AD/ADRD. 7 10 11 In addition, we found that insomnia-related sleep/circadian disruption correlated with amyloid/tau burden decades before dementia. 12 13 All the above factors have been implicated in PND pathophysiology. Despite these impacts on brain health, insomnia symptoms are rarely screened for, and few evidence-based treatments exist to optimise sleep before surgery. Cognitive Behavioural Therapy for Insomnia (CBT-I) has been the first line of treatment for insomnia for over a decade, effective in reducing chronic insomnia, anxiety and depressive symptoms, 14 and improving pain tolerance. However, the efficacy of an abbreviated CBT-I treatment in perioperative older patients with insomnia remains unclear. Thus, the Sleep Optimisation for B rain Health O utcomes in O lder S urgical Patien t s ( SLEEP-BOOST ) pilot trial addresses this gap by testing the feasibility and preliminary efficacy of a condensed digital CBT-I (dCBT-I) intervention delivered before and after elective orthopaedic surgery. Although CBT-I shares certain elements with mindfulness, pain-coping and relaxation-based therapies, it is unique in its targeted focus on correcting maladaptive sleep behaviours, restructuring dysfunctional sleep-related cognitions and consolidating sleep to strengthen both homeostatic and circadian regulation. To our knowledge, this is the first study to evaluate the feasibility and efficacy of a preoperative, digitally delivered CBT-I intervention in perioperative older surgical patients, thus assessing feasibility with the goal of informing a scalable approach that may expand access to evidence-based insomnia treatment in a high-burden population. Trial objectives The primary objective of this trial is to establish the feasibility of the dCBT-I protocol in older surgical patients with insomnia symptoms by assessing adherence and retention. Secondary objectives are to explore preliminary effects of the intervention on clinical outcomes, including insomnia severity, cognitive trajectory, sleep, pain, mood and motor functions. This study will explore whether participants receiving dCBT-I show improvements in insomnia symptoms and postoperative outcomes compared with those receiving sleep hygiene education alone. Methods Overview of the study design This protocol is a randomised controlled trial designed to evaluate the feasibility and acceptability of a condensed dCBT-I intervention perioperatively in older adults undergoing elective knee or hip replacement. 50 older patients scheduled for hip or knee replacement elective surgery with mild insomnia symptoms will be recruited. Study registration This study is registered with the US National Institutes of Health (NIH) on ClinicalTrials.gov ( NCT06375265 ) and approved by the Institutional Review Board (IRB) at Massachusetts General Hospital (MGH) (Protocol #2024P000780). Recruitment is scheduled to occur between January 2025 and December 2026. Participants Recruitment procedures All recruitment procedures will be conducted at MGH. Potential participants, older adults scheduled for elective knee or hip replacement surgery, will be identified using two primary pathways via Patient Gateway electronic letters and in-clinic engagement. All individuals interested in participating in the study can indicate their interest using online surveys or direct contact with the study team. Eligible participants will provide informed consent prior to enrolment. An example of the participant consent form is provided in online supplemental material 1 . All interested individuals will undergo an eligibility screening procedure by a study team member, followed by review of their medical record to confirm eligibility criteria before enrolment. Eligibility criteria A total of 50 participants will be enrolled in this pilot study. All inclusion and exclusion criteria are detailed in table 1 . Eligibility will be determined through a structured review of the electronic medical record (EMR), supplemented by participant self-report when necessary. Table 1. Eligibility criteria and rationale. Eligibility category Criteria Rationale Inclusion Age≥65 years Target population at elevated risk for developing PND Scheduled for elective total knee or hip replacement Ensures consistent perioperative course and follow-up availability Insomnia Severity Index (ISI)≥10 retrieve via telephone or REDCap screening Confirms at least mild–moderate insomnia symptoms appropriate for CBT-I. We are targeting those who may benefit the most (ie, some clinical manifestation of insomnia) Owns a smartphone Required for accessing the digital CBT-I intervention and study communication Willingness to use the digital CBT-I app and wear actigraphy study device Ensures feasibility of delivering the intervention and collecting sleep data Exclusion Current or previous CBT-I exposure in the last 6 months prior to the start of the study Prevents contamination and ensures CBT-I is a novel intervention Rapidly progressive illness or life expectancy<6 months Ensures ability to complete study procedures and follow-up Active psychosis or suicidal ideation Safety concerns; incompatible with behavioural intervention Irregular shift work/sleep patterns Pre-existing disruptions in circadian rhythm and sleep timing may confound the assessment of sleep outcomes and response to the intervention Moderate–severe sleep apnoea (AHI≥15) without Continuous Positive Airway Pressure compliance per chart review (EMR and/or self-report). Sleep apnoea status is determined through structured chart review and participant self-report; no additional screening procedures are performed Sleep disorders other than insomnia or sleep apnoea (identified via EMR and/or self-report) Untreated apnoea or other sleep disorders may confound insomnia symptoms and primary outcomes Cognitive impairment (dementia diagnosis by chart review) Ensures capacity to engage in CBT-I techniques and complete assessments Initiation, discontinuation, or dose change of sleep-affecting prescription medications within 1 month prior to study start or during the intervention period. Participants on stable sleep-affecting medication regimens for≥1 month prior to enrolment will not be excluded, by clinical review Ensures a steady state for sleep-affecting medications before trial enrolment No surgery within 12 months of consent; eligibility will be reassessed if surgery is delayed by more than 3 months Ensures appropriate timing between intervention and surgery; reassessment accounts for changes with surgical delays Open in a new tab AHI, Apnoea-Hypopnoea Index; CBT-I, Cognitive Behavioural Therapy for Insomnia; CPAP, continuous positive airway pressure; EMR, electronic medical record; PND, postoperative neurocognitive disorders; REDCap, Research Electronic Data Capture. Diagnoses of moderate to severe obstructive sleep apnoea will be identified based on prior sleep studies documented in the EMR (Apnoea-Hypopnoea Index (AHI)≥15), when available. Continuous positive airway pressure adherence will be determined based on documentation in the medical record (eg, clinician notes or device reports) and/or participant self-report of regular use. Other sleep disorders will be identified through EMR review of documented diagnoses and clinical notes, with clarification via participant report when needed. Cognitive impairment will be defined based on documented diagnoses in the EMR (eg, mild cognitive impairment or dementia), and participants must demonstrate the capacity to provide informed consent. Randomisation After informed consent and completion of enrolment procedures, participants will be randomised in a 1:1 ratio to either the condensed CBT-I intervention ( Treatment arm ) or a patient contact-matched Sleep Hygiene Education group ( Control arm ). Randomisation and allocation concealment The allocation sequence was generated before the start of recruitment using a computer-based permuted block randomisation scheme with a fixed block size of ten to ensure balanced group assignment. The randomisation list was generated and maintained by designated unblinded study personnel not involved in participant outcome assessments. The allocation list was stored in a secure electronic study folder with restricted access limited to the Principal Investigator, project manager and designated unblinded study personnel responsible for intervention delivery. Allocation was revealed only after participant enrolment and baseline assessments were completed. Blinding Due to the behavioural nature of the intervention, participants and study personnel responsible for intervention delivery were not blinded to group allocation. Participants were not explicitly informed of their group assignment; however, complete participant blinding was not feasible, which is consistent with prior CBT-I trials. Unblinded study personnel conducted all intervention sessions from Session 1 through the 1-month follow-up visit. Outcome assessments at the 3-month follow-up were conducted by designated blinded study personnel who were not involved in intervention delivery and did not have access to the randomisation list. Efforts were made to maintain blinding of outcome assessors throughout the study. Study intervention All participants will complete three preoperative sessions ( Baseline, Session 2, and Session 3 approximately once a week) and three postoperative sessions (2 weeks and 1 and 3 months after surgery). The content of each session is detailed and summarised below in table 2 . Table 2. Material covered during the sleep intervention comparison between groups over time. Session Control arm Treatment arm Enrollment (Day 0) Sleep diary introduction Participants will complete their sleep diary daily until their surgery day Sleep diary introduction Participants will complete their sleep diary daily until their surgery day Baseline (Day 7) Sleep education (two-process model of sleep (homeostatic and circadian regulation)) Common sleep hygiene tips (ie, avoid caffeine, alcohol and intense exercise a couple of hours before bed, avoid screens and check bedroom temperature) Sleep goals (establish specific, achievable targets for improving sleep to focus on over the upcoming week) Sleep education (two-process model of sleep (homeostatic and circadian regulation), 3Ps model of insomnia (predisposing, precipitating and perpetuating factors)) Sleep hygiene (lifestyle habits that affect sleep, such as caffeine intake, screen time and creating a proper sleep environment) Stimulus control (re-associating the bed and bedroom with sleep by establishing a consistent routine, such as getting out of bed if one cannot sleep after 15 min) Sleep restriction (limiting the time spent in bed to match the amount of time one is actually sleeping to help increase sleep drive and efficiency) Sleep goals (establish specific, achievable targets for improving sleep to focus on over the upcoming week) Additional resources : CBT-I coach app introduction and homework (ie, readings and survey assessment) Session 2 (Day 14) Sleep education (3Ps model of insomnia (predisposing, precipitating and perpetuating factors)) Sleep hygiene tips refresher Sleep goals Relaxation techniques (methods like deep breathing, progressive muscle relaxation or mindfulness to reduce physical and mental arousal, preparing the body for sleep) Cognitive restructuring (identifying and reframing maladaptive sleep-related thoughts) Discussion about the homework left in the previous session Session 3 (Day 20) Final check-in before surgery will be a review session and opportunity for questions to be answered. Final check-in before surgery will reinforce learnt strategies, address any remaining questions and provide end-of-treatment advice (eg, not following the sleep restriction schedule on the night before surgery) Day of Surgery 2-week follow-up Quick review of SHE components: Two-process model of sleep 3Ps model of insomnia Common sleep hygiene tips (ie, avoid caffeine, alcohol and intense exercise a couple of hours before bed, avoid screens and check bedroom temperature) Sleep goals Quick review of CBT-I components: Sleep education Sleep hygiene Stimulus control Sleep restriction (new sleep window given at this time) Relaxation techniques Cognitive restructuring Sleep goals CBT-I coach app homework 1-month follow-up Final session of the SHE component: review of key content and opportunity to address questions. Final session of the sleep intervention: review of strategies, reinforcement of key content, discussion of prior homework and end-of-treatment guidance (eg, gradual relaxation of sleep restriction by adjusting bedtime in 15 min increments daily or 30 min increments weekly). 3-month follow-up Last study follow-up: completion of assessment questionnaires (mood, pain, cognition and sleep measures; see table 3 ). Open in a new tab CBT-I, Cognitive Behavioural Therapy for Insomnia; SHE, Sleep Hygiene Education. Intervention delivery format All interventions will be delivered in a hybrid format (in-person or live video-based) by trained study personnel, with matched session timing and participant contact across study arms. Each participant will complete five intervention sessions spanning the preoperative and postoperative periods, followed by a follow-up session for outcome assessment only. Treatment arm Participants randomised to the Treatment arm will complete a condensed dCBT-I intervention delivered across five intervention sessions. The first session, occurring approximately 2 weeks before surgery, includes baseline assessments and introduction to foundational CBT-I components, including sleep education (Two-Process Model; 3Ps Model), sleep hygiene, stimulus control and sleep restriction. Sleep diary data from the baseline week will be used to prescribe the individualised sleep-restriction window. Participants will also be oriented to the CBT-I Coach mobile application, which they will use to support skill practice (eg, goal setting and reinforcement of CBT-I strategies with homework completion: Dysfunctional Beliefs and Attitudes about Sleep (DBAS) questionnaire) between sessions and to facilitate adherence. The second session reinforces material from the first visit and introduces additional CBT-I components, including relaxation techniques and cognitive restructuring. Sleep-restriction recommendations are reviewed and adjusted based on updated sleep diary data. The third session, conducted one to 2 days prior to the surgery, serves as the final preoperative check-in focused on consolidating learnt strategies, addressing barriers and reviewing progress. No new treatment components will be introduced on this visit. The fourth session, conducted at 2 weeks post-surgery, will include a review of core CBT-I components and re-evaluation of the sleep-restriction schedule, with adjustments based on updated sleep data. The fifth session, conducted at 1 month post-surgery, will serve as the final intervention session and will include reinforcement of strategies, review of prior homework and end-of-treatment guidance (eg, gradual relaxation of sleep restriction). The 3-month follow-up will consist of study assessments only. Control arm Participants in the Control arm will complete a standardised Sleep Hygiene Education (SHE) programme matched to the treatment arm in timing and contact frequency (five sessions). During the first session, participants complete baseline assessments and receive education on general sleep hygiene principles and the Two-Process Model of Sleep. The second session includes repeated sleep assessments and introduces the 3Ps Model of Insomnia, along with reinforcement of previously taught sleep hygiene concepts. The third session, conducted one to 1–2 days before surgery, serves as the final check-in which includes addressing questions and ensuring adherence to actigraphy and sleep diary procedures. No new therapeutic content is introduced in this session. The fourth session, conducted at 2 weeks post-surgery, will include a review of key sleep hygiene concepts. The fifth session, conducted at 1 month post-surgery, will serve as the final SHE session and will include reinforcement of key content and an opportunity to address questions. The 3-month follow-up will consist of study assessments only. Study procedures and outcome measures Primary outcomes The primary outcomes of this pilot trial are feasibility and adherence to the intervention. Adherence . Adherence to the CBT-I intervention will be assessed using the Patient Adherence Form developed by the Veterans Affairs Cognitive Behavioural Therapy for Insomnia Training Programme. 15 This instrument evaluates adherence across six domains and has demonstrated strong psychometric properties. A mean adherence score will be calculated for each participant. 16 Adherence will be evaluated following completion of the intervention during the preoperative review (session 3). Additional adherence indicators will include the number of days of completed sleep diaries and the amount of time participants spend engaging in assigned intervention activities (ie, homework completion). Insomnia severity . Insomnia severity will be assessed using the Insomnia Severity Index (ISI), a 7-item self-report scale that evaluates the nature, severity and impact of insomnia symptoms. Each item is rated on a 5-point Likert scale from 0 (‘no problem’) to 4 (‘very severe problem’), yielding a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity (10–14 mild, 15–21 moderate and≥22 severe). In line with the pilot design, changes in ISI over time will be treated as an exploratory clinical outcome to estimate preliminary effects of the intervention. Secondary outcomes Sleep-related outcomes . Sleep outcomes will be derived from both sleep diaries and continuous wrist actigraphy collected during the 3-week preoperative period and for 7 days surrounding each postoperative follow-up. Participants will wear a wrist-watch device (Enduro 2, Garmin Inc, Olathe, Kansas, USA; and Philips Actiwatch, Spectrum Plus, Actigraphy Motion Biosensors, Bend, Oregon, USA) to record activity throughout these monitoring periods. Device comparability was evaluated prior to implementation and supporting data demonstrating similar activity count outputs are provided in online supplemental material 2 . Daily sleep diary will be used to support the identification of the sleep-wake periods estimated by the actigraphy device. Sleep diary variables—including time in bed, lights-out time, sleep latency, nighttime awakenings and final wake time—will be extracted to calculate sleep outcomes. Key sleep outcomes will include sleep onset latency, wake after sleep onset, total sleep time (derived from bedtime, wake time and diary-reported nocturnal wake intervals) and sleep efficiency (percentage of time in bed spent asleep). Preoperative and postoperative values for all sleep variables will be calculated as weekly averages for each monitoring period. Sleep diary completion will also be recorded as the number of days with completed entries throughout the study period. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, a validated 19-item instrument that provides a global score of subjective sleep quality. Cognitive outcomes . Cognitive trajectory will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA will be administered at baseline, during the postoperative inpatient period (up to postoperative day 3) and again at 2 weeks, 1 month and 3 months following surgery. When in-person assessment is not feasible, trained study staff will administer the telephonic MoCA (tMoCA) as a validated alternative. Participants will be contacted for postoperative cognitive assessments even if they have already been discharged from the hospital. Failure to complete the tMoCA on postoperative days 2 or 3 will not be classified as a study deviation. PND and delirium outcomes . Postoperative delirium will be assessed using the 3D Confusion Assessment Method (3D-CAM) and CAM-Severity scale, administered twice daily during the inpatient period within the first three postoperative days. Delayed neurocognitive recovery and PND will be evaluated at 1-month and 3-month follow-up visits using standard cognitive criteria. Delayed neurocognitive recovery (1 month) and PND (3 months) will be defined as a≥1 SD decline from baseline cognitive performance. Pain, mood and functional outcomes . Pain will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, and functional outcomes will be assessed using the WOMAC physical function subscale. Pain and function will be assessed at baseline, at the end of the preoperative intervention, and at 2 weeks, 1 month and 3 months after surgery. Mood will be assessed using the Geriatric Depression Scale, and anxiety symptoms will be assessed using the Generalised Anxiety Disorder–7 scale, at baseline and at 1 and 3 months postoperatively. Satisfaction and utility . Participant satisfaction and perceived utility of the intervention will be assessed before surgery during session 3. In the treatment arm, a 16-item digital intervention utility questionnaire 17 will be used to assess participants’ perceived utility and engagement of the digital application (score range: 0–64; higher scores indicate greater perceived utility). Satisfaction with the intervention will be assessed in both study arms with a 9-item survey 18 designed to identify which components of the intervention were perceived as most helpful and the participants’ likelihood of recommending the intervention to family or friends. These measures will be used to further characterise feasibility, acceptability, and participant engagement. All secondary outcomes will be treated as exploratory and used to estimate preliminary effects and inform the design of future trials. Exploratory outcomes Circadian rest–activity rhythm features—including amplitude, acrophase, interdaily stability, intradaily variability, most active 10 hours, least active 5 hour, relative amplitude and fractal motor activity regulation activity measures—will be derived from wrist actigraphy using established analytical methods described in our prior work. 19 These parameters will provide complementary information on circadian rhythmicity, sleep–wake consolidation and activity pattern fragmentation. The schedule of enrolment, interventions and assessments is presented in table 3 , in accordance with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Table 3. Schedule of enrolment, interventions and assessments (SPIRIT format). Enrolment Session 1 Session 2 Session 3 Post-op 2-week FU 1-month FU 3 Month FU Day 0 Day 7 Day 14 Day 20 Days 22–24 Day 35 Day 49 Day 109 Enrolment Eligibility screen X Informed consent X Randomisation X Intervention/comparator dCBT-I (treatment arm) X X X X X SHE (control arm) X X X X X Assessments Sleep questionnaires (PSQI, ISI) X X X X X X Sleep measures (actigraphy, diary) X X X X X X X CAM X X (twice daily) MoCA/t-MoCA X X X X Pain (WOMAC) X X X X X Mood (GAD-7, GDS) X X Adherence/satisfaction/utility X X Blood collection X X Open in a new tab CAM, Confusion Assessment Method; dCBT-I, digital Cognitive Behavioural Therapy for Insomnia; eMR, electronic medical record; FU, follow-up session; GAD-7, General Anxiety Disorder-7; GDS, Geriatric Depression Scale; ISI, Insomnia Severity Index; MoCA/tMoCA, (telephonic) Montreal Cognitive Assessment; PSQI, Pittsburg Sleep Quality Index; SHE, Sleep Hygiene Education; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index. Ancillary data collection Blood samples will be collected at up to three points: twice during the preoperative period and once during the early postoperative period. When feasible, blood draws will be coordinated with routine clinical care, including collection at the time of initial intravenous placement by anaesthesia staff or via an indwelling line while the patient is under general anaesthesia, to minimise participant burden. Preoperative blood draws will occur at baseline (10 mL; within 30 days before surgery) and on the day of surgery (20 mL; within 0–2 hours prior to surgery). The postoperative blood draw will be obtained during the early postoperative period (10 mL; postoperative days 1–3), as feasible, to maximise collection success while avoiding interference with clinical care. Collected blood samples will be used for exploratory mechanistic analyses and are not designated as primary or secondary trial outcomes. Data analysis Sample size justification This pilot trial is designed to evaluate feasibility and to generate preliminary effect-size estimates to inform a future fully powered study. The sample size selection was informed by prior CBT-I studies demonstrating large treatment effects on insomnia severity; however, in line with the exploratory nature of this pilot, formal hypothesis testing is not the primary objective. 20 , 22 Based on these prior findings, a sample of 38 participants would be sufficient to detect a clinically meaningful change in ISI scores (approximately 4–5 points) under assumptions of a large effect size (Cohen’s d≈0.9). To account for potential attrition (estimated at 20–25%), we plan to recruit 50 participants. Thus, the selected sample size is adequate to assess the feasibility outcomes (ie, adherence, retention) and to estimate the magnitude and variability of treatment effects for planning future trials. Statistical analysis Descriptive statistics (means, SD, frequencies) will be used to summarise feasibility and acceptability metrics, including adherence, utility and satisfaction. Exploratory comparisons of continuous variables between groups will be conducted using independent-samples t-tests, and within-group changes over time will be evaluated using paired t-tests. The primary and secondary outcomes will be analysed using an intention-to-treat framework, with all randomised participants included in the analyses regardless of intervention completion. Potential confounders and covariates known to influence perioperative sleep and recovery (eg, age, sex, comorbidities) will be recorded to evaluate balance across treatment groups following randomisation. If imbalance is detected, covariate-adjusted models may be applied. Postoperative pain (WOMAC) will be examined as an outcome of interest and may be included as a covariate in exploratory analyses to account for its potential influence on sleep outcomes and variability over time. Sensitivity analyses will assess the influence of clinical heterogeneity and biological sex on observed effects. Additional exploratory analyses may evaluate dose–response relationships between adherence metrics and clinical outcomes. Given the pilot nature of the study, analyses are intended to estimate effect sizes and variability rather than to support confirmatory hypothesis testing. Data monitoring, management and quality assurance Data, including demographics and assessment measures, will be stored in the Research Electronic Data Capture (REDCap) database. For data quality assurance, data entries will be monitored regularly by study staff and Principal Investigator (PI). Data confidentiality will be maintained using password-protected secure servers and authorised access to study team members only. The PI will be responsible for monitoring the validity and integrity of the data and adherence to the IRB-approved protocol. Adverse events will be reported promptly in accordance with institutional and IRB requirements. All serious adverse events will be reported according to institutional timelines for reporting events through appropriate channels of the MGH Human Research Committee. A Scientific Review will occur annually and consist of a review of subject recruitment, staff training, and quality control procedures. Monitoring progress reports will be submitted to regulatory and/or funding bodies (IRB, NIH) as required. Cohort retention strategies Participant retention will be supported through regular study contact and proactive engagement throughout the intervention and follow-up period. Participants will be provided with a designated study contact for questions related to the digital CBT-I application and wrist-worn actigraphy device to address technical issues and reinforce engagement. Additional follow-up contacts will occur at 2 weeks, 1 and 3 months after surgery. Participant withdrawal remains voluntary. Based on prior experience with similar protocols, these procedures are expected to support high retention and minimise attrition. Patient and public involvement Patient advisers were not involved in this research study’s design, conduct, reporting or dissemination plans. However, patient-reported outcome measures from questionnaires will be evaluated as a secondary outcome. The study is registered on ClinicalTrials.gov and updated at regular intervals. Results will be reported in a time-compliant manner on ClinicalTrials.gov . Ethics and dissemination This trial was approved by the Institutional Review Board at Massachusetts General Hospital (MGH), Boston, MA. Electronic patient information will be accessed only as necessary throughout the completion of the study. Plans for dissemination include conference presentations at a variety of scientific institutions. Results from this study are intended to be published in peer-reviewed journals. Relevant updates will be made available on ClinicalTrials.gov. Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award. The study data will be stored in the repository for at least 5 years. All data will be de-identified. Per standard Partners HealthCare System policies, we will require from any investigator or entity requesting the data a data-sharing agreement that provides (1) a commitment to using the data only for research purposes and not to identify any individual participants, (2) a commitment to securing the data using appropriate computer technology and (3) a commitment to destroying or returning the data after analyses are completed. Supplementary material online supplemental file 1 bmjopen-16-5-s001.pdf (290.9KB, pdf) DOI: 10.1136/bmjopen-2026-116526 online supplemental file 2 bmjopen-16-5-s002.pdf (64.9KB, pdf) DOI: 10.1136/bmjopen-2026-116526 Acknowledgements The authors would like to acknowledge all members and patients involved in the conduct of this study. Footnotes Funding: The work is funded by the National Institute of Health (NIH) grant R03AG087439 and supported by the Anaesthesia Research Core (ARC) within the Department of Anaesthesia, Critical Care and Pain Medicine (DACCPM) at the Massachusetts General Hospital, Harvard Medical School. Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online ( https://doi.org/10.1136/bmjopen-2026-116526 ). Provenance and peer review: Not commissioned; externally peer reviewed. Patient consent for publication: Not applicable. Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research. References 1. Lin D, Huang X, Sun Y, et al. Perioperative Sleep Disorder: A Review. Front Med. 2021;8:640416. doi: 10.3389/fmed.2021.640416. [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 2. 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Supplementary Materials online supplemental file 1 bmjopen-16-5-s001.pdf (290.9KB, pdf) DOI: 10.1136/bmjopen-2026-116526 online supplemental file 2 bmjopen-16-5-s002.pdf (64.9KB, pdf) DOI: 10.1136/bmjopen-2026-116526 Articles from BMJ Open are provided here courtesy of BMJ Publishing Group ACTIONS View on publisher site PDF (293.5 KB) Cite Collections Permalink RESOURCES Similar articles Cited by other articles Links to NCBI Databases Follow NCBI NCBI on X (formerly known as Twitter) NCBI on Facebook NCBI on LinkedIn NCBI on GitHub NCBI RSS feed Connect with NLM NLM on X (formerly known as Twitter) NLM on Facebook NLM on YouTube National Library of Medicine 8600 Rockville Pike Bethesda, MD 20894 Web Policies FOIA HHS Vulnerability Disclosure Help Accessibility Careers NLM NIH HHS USA.gov Back to Top

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