Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
- Conditions
- Delayed Neurocognitive RecoveryInsomniaPostoperative DeliriumPostoperative Neurocognitive Disorder
- Interventions
- Behavioral: Sleep Health EducationBehavioral: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
- Registration Number
- NCT06375265
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Adults ≥ 65 years old
- Scheduled for an elective orthopedic total joint replacement procedure (knee/hip) with an anticipated stay of ≥48 hours
- At least mild insomnia (ISI score of ≥10 on telephone screening)
- Stable sleep-affecting medications in the prior month (by clinical review)
- Own a smart phone
- Willingness to use the dCBT-I app and actigraphy.
- Current or previous CBT-I
- Rapidly progressive illnesses/life expectancy <6 months
- Active psychosis/suicidal ideation
- Irregular shift work/sleep patterns
- Moderate-severe sleep apnea (apnea/hypopnea index ≥15) without CPAP compliance per chart review
- Sleep disorders other than insomnia or apnea
- Cognitive impairment (diagnosis of dementia)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep Health Education Sleep Health Education Preoperative sleep health education materials Digital CBT-I digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) Preoperative digital CBT-I with the CBT-I Coach app and up to 4 weekly sessions
- Primary Outcome Measures
Name Time Method Adherence After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery. 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)
Insomnia Severity At screening, baseline, during dCBT-I/control, 2 weeks, 1- and 3-months after surgery 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)
- Secondary Outcome Measures
Name Time Method Sleep Efficiency At baseline, immediately after the intervention, and 2 weeks, 1- and 3-months after surgery Actigraphy and diary-derived
Sleep Diary Completion Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery. The number of days of completed sleep diaries will be recorded.
Homework Completion After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery. The amount of time spent on CBT-I homework will be recorded.
Utility After dCBT-I intervention during Review session ~1 day to 1 week before surgery. A 16-item digital intervention utility questionnaire will be used to assess patient usage of the app (0-64; higher represents more perceived utility)
Satisfaction with intervention After dCBT-I intervention during Review session ~1 days to 1 week before surgery. 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.
Cognition At baseline and 2 weeks, 1- and 3-months after surgery Telephonic Montreal Cognitive Assessment (tMoCA) test to assess cognition
Pain severity At baseline and 2 weeks, 1- and 3-months after surgery Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain will measure functional pain severity
Mood At baseline and 1- and 3-months after surgery The Geriatric Depression Scale-15 will be used to assess the mood of the patients (0-15; higher represents more severe mood/depression symptoms)
Anxiety At baseline and 1- and 3-months after surgery Generalize Anxiety Disorder 7 (GAD-7; 0-21; higher represents more anxiety symptoms)
Function At baseline and 2 weeks, 1- and 3-months after surgery Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function
Postoperative Delirium Incidence From postoperative day 1 to postoperative day 3 The Confusion Assessment Method (3D-CAM) will be used to monitor signs of delirium in patients.
Postoperative Delirium Severity From postoperative day 1 to postoperative day 3 The Confusion Assessment Method (CAM)-Severity assessment will be used to monitor signs of delirium severity in patients.
Delayed Neurocognitive Recovery At 1-months after surgery Using cognitive change from baseline (1 standard deviation from the mean).
Postoperative Neurocognitive Disorders (NCD) At 3-months after surgery Using cognitive change from baseline (1 standard deviation from the mean).
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States