Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Not Applicable

Recruiting

• Conditions: Delayed Neurocognitive Recovery; Insomnia; Postoperative Delirium; Postoperative Neurocognitive Disorder

• 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).

Study Timeline

• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Study Start: 2025-01-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-05-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Adults ≥ 65 years old
2. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip) with an anticipated stay of ≥48 hours
3. At least mild insomnia (ISI score of ≥10 on telephone screening)
4. Stable sleep-affecting medications in the prior month (by clinical review)
5. Own a smart phone
6. Willingness to use the dCBT-I app and actigraphy.

Exclusion Criteria

1. Current or previous CBT-I
2. Rapidly progressive illnesses/life expectancy <6 months
3. Active psychosis/suicidal ideation
4. Irregular shift work/sleep patterns
5. Moderate-severe sleep apnea (apnea/hypopnea index ≥15) without CPAP compliance per chart review
6. Sleep disorders other than insomnia or apnea
7. Cognitive impairment (diagnosis of dementia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 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).
Sleep Efficiency	At baseline, immediately after the intervention, and 2 weeks, 1- and 3-months after surgery	Actigraphy and diary-derived

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States