Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Insomnia Clinical Trial

— SLEEP-BOOST  

Official title:

A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375265
• Other study ID #: 2024P000780-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 31, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Lei Gao, MD
• Phone: 617-726-3030
• Email: lgao[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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) per chart review

6. Sleep disorders other than insomnia or apnea

7. Cognitive impairment (diagnosis of dementia)

Related Conditions & MeSH terms

• Emergence Delirium
• Insomnia
• Neurocognitive Disorders
• Postoperative Delirium

Intervention

Behavioral:
• digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
Preoperative hybrid intervention (in-person or via phone/video) over 4 weeks using content from the CBT-I Coach app from Veteran Affairs.
• Sleep Health Education
Sleep Health Education materials provided

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 1- and 3-months after surgery
Primary	Adherence	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 ~3 days to 1 week before surgery.
Primary	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 baseline, after dCBT-I/control, and 1- and 3-months after surgery
Secondary	Sleep Diary Completion	The number of days of completed sleep diaries will be recorded.	After dCBT-I intervention during Review session ~3 days to 1 week before surgery.
Secondary	Homework Completion	The amount of time spent on CBT-I homework will be recorded.	After dCBT-I intervention during Review session ~3 days to 1 week before surgery.
Secondary	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 ~3 days to 1 week before surgery.
Secondary	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 ~3 days to 1 week before surgery.
Secondary	Cognition	Telephonic Montreal Cognitive Assessment (tMoCA) test to assess cognition	At baseline and 1- and 3-months after surgery
Secondary	Pain severity	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain will measure functional pain severity	At baseline and 1- and 3-months after surgery
Secondary	Mood	The Geriatric Depression Scale-15 will be used to assess the mood of the patients (0-15; higher represents more severe mood/depression symptoms)	At baseline and 1- and 3-months after surgery
Secondary	Anxiety	Generalize Anxiety Disorder 7 (GAD-7; 0-21; higher represents more anxiety symptoms)	At baseline and 1- and 3-months after surgery
Secondary	Function	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function	At baseline and 1- and 3-months after surgery
Secondary	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
Secondary	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
Secondary	Delayed Neurocognitive Recovery	Using cognitive change from baseline (1 standard deviation from the mean).	At 1-months after surgery
Secondary	Postoperative Neurocognitive Disorders (NCD)	Using cognitive change from baseline (1 standard deviation from the mean).	At 3-months after surgery
Secondary	Sleep Efficiency	Actigraphy and diary-derived	At baseline, immediately after the intervention, and 1- and 3-months after surgery