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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).
CBT-I is the frontline treatment for insomnia but is not considered for preoperative care of older surgical patients with insomnia who are at risk of perioperative neurocognitive disorders associated with sleep/circadian dysfunction. We propose to determine if digital CBT-I (dCBT-I) is feasible for treating older surgical patients with insomnia symptoms and to examine the effects of dCBT-I on sleep, cognitive trajectory, mood, pain, activity, and function after surgery. The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested CBT-I mobile application paired with a wearable device (wrist actigraphy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital CBT-I | Experimental | Preoperative digital CBT-I with the CBT-I Coach app for up to 4 weekly sessions and postoperative booster sessions at 2 weeks and 1 month after surgery. |
|
| Sleep Health Education | Active Comparator | Preoperative sleep health education materials |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) | Behavioral | Preoperative hybrid intervention (in-person or via phone/video) over 4 weeks, and at 2 weeks, and 1 month after surgery using content from the CBT-I Coach app from Veteran Affairs. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence: CBT-I | A Patient Adherence Form developed by the Veterans Affairs CBT-I Training Program will be used to assess adherence to the protocol. A mean adherence score across six domains showing good psychometric properties will be derived (0-24; higher represents more adherent) | After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery. |
| Adherence: Sleep Diary/Actigraphy | The number of days of completed sleep diaries and actigraphy will be recorded. | Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery. |
| Adherence: Homework Completion | The amount of time spent on CBT-I homework will be recorded. | After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery. |
| Insomnia Severity | The Insomnia Severity Index (ISI) questionnaire will be used to determine the quality of sleep for patients (0 to 28; higher represents more severe insomnia symptoms) | At screening, baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | The Pittsburgh Sleep Quality Index (PSQI) questionnaire will be used to assess subjective sleep quality in patients (range 0 to 21; higher scores indicate worse sleep quality). | At baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian Rest-Activity Rhythms | Motor activity will be recorded on wrist actigraphy watches to derive amplitude, acrophase, interdaily stability, intradaily variability, most active 10h (M10), least active 5h (L5), relative amplitude (RA), fractal motor activity regulation (FMAR). | At baseline, immediately after the intervention, and 2 weeks, 1- and 3-months after surgery |
Inclusion Criteria:
5. Own a smart phone 6. Willingness to use the dCBT-I app and actigraphy.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Castillo, BS | Contact | 4695094163 | acastillo17@mgh.harvard.edu | |
| Mili Jimenez Gallardo | Contact | mjimenezgallardo@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lei Gao, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42209013 | Derived | Charles AE, Castillo Suarez AA, Chhajed M, Jimenez Gallardo M, Sanchez Valdes K, Li P, Hu K, Wong PM, Winkelman J, Gao L. Perioperative sleep optimisation and brain health in older adults (SLEEP-BOOST): protocol for a randomised controlled trial. BMJ Open. 2026 May 28;16(5):e116526. doi: 10.1136/bmjopen-2026-116526. |
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| Sleep Health Education | Behavioral | Sleep Health Education materials provided |
|
| Utility |
A 16-item digital intervention utility questionnaire will be used to assess patient usage of the app (0-64; higher represents more perceived utility) |
| After dCBT-I intervention during Review session ~1 day to 1 week before surgery. |
| Satisfaction with intervention | A 9-item survey will be used to assess which elements of the app were most helpful and the likelihood the patient would recommend it to family/friends. | After dCBT-I intervention during Review session ~1 days to 1 week before surgery. |
| Cognition | Telephonic Montreal Cognitive Assessment (tMoCA) test to assess cognition | At baseline and 2 weeks, 1- and 3-months after surgery |
| Pain severity and Function | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain will measure functional pain severity | At baseline, end of the dCBTI/control intervention pre-surgery and 2 weeks, 1- and 3-months after surgery |
| Mood/Anxiety | The Geriatric Depression Scale-15 will be used to assess the mood of the patients (0-15; higher represents more severe mood/depression symptoms). Generalize Anxiety Disorder 7 (GAD-7; 0-21; higher represents more anxiety symptoms) | At baseline and 1- and 3-months after surgery |
| Postoperative Delirium Incidence | The Confusion Assessment Method (3D-CAM) will be used to monitor signs of delirium in patients. | From postoperative day 1 to postoperative day 3 |
| Postoperative Delirium Severity | The Confusion Assessment Method (CAM)-Severity assessment will be used to monitor signs of delirium severity in patients. | From postoperative day 1 to postoperative day 3 |
| Delayed Neurocognitive Recovery | Using cognitive change from baseline (1 standard deviation from the mean). | At 1-months after surgery |
| Postoperative Neurocognitive Disorders (NCD) | Using cognitive change from baseline (1 standard deviation from the mean). | At 3-months after surgery |
| Ancillary Data Collection | Collection of blood samples from participant | Before baseline session, on surgery day, and once on post-operative days 1-3 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
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