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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Postoperative Delirium; Delayed Neurocognitive Recovery; Postoperative Neurocognitive Disorder
• Intervention / Treatment: Behavioral: Sleep Health Education; Behavioral: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Castillo, BS; Phone Number: 4695094163; Email: acastillo17@mgh.harvard.edu
• Study Contact Backup: Name: Mili Jimenez Gallardo; Email: mjimenezgallardo@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Andrea Castillo, BS; Phone Number: 4695094163; Email: acastillo17@mgh.harvard.edu
      • Contact: Lei Gao, MD; Phone Number: 6178882941; Email: lgao@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults ≥ 65 years old
2. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip)
3. At least mild insomnia (ISI score of ≥10 on telephone screening or RedCap screening questionnaire)

5. Own a smart phone 6. Willingness to use the dCBT-I app and actigraphy.

Exclusion Criteria:

1. Current or previous CBT-I exposure in the last 6 months prior to the start of the study
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)
8. Initiation, discontinuation, or dose change of sleep-affecting prescription medications within 1 month prior to study start or during the intervention period; not excluded if stable sleep-affecting medications in the prior month (by clinical review)
9. No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sleep Health Education; Preoperative sleep health education materials	Behavioral: Sleep Health Education; Sleep Health Education materials provided
Experimental: Digital CBT-I; 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.	Behavioral: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	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
Ancillary Data Collection	Collection of blood samples from participant	Before baseline session, on surgery day, and once on post-operative days 1-3

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Lei Gao, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2024P000780-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No