What this study is
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).
What's being tested
- digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
Intervention · 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.
- Sleep Health Education
Intervention · BEHAVIORAL
Sleep Health Education materials provided
Study details
- Official title
- A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)
- Sponsor
- Massachusetts General Hospital
- Conditions
- Insomnia · Postoperative Delirium · Delayed Neurocognitive Recovery · Postoperative Neurocognitive Disorder
- Enrolling
- 50 people
- Starts
- 2025-01-15
- Est. completion
- 2026-12-31
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 65 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adults ≥ 65 years old
- Scheduled for an elective orthopedic total joint replacement procedure (knee/hip)
- At least mild insomnia (ISI score of ≥10 on telephone screening or RedCap screening questionnaire)
- Own a smart phone 6. Willingness to use the dCBT-I app and actigraphy.
You can't join if
- Current or previous CBT-I exposure in the last 6 months prior to the start of the study
- 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)
- 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)
- No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts General Hospital
Boston, Massachusetts, United States
- Lei Gao, MD · Contact6178882941lgao@mgh.harvard.edu
- Andrea Castillo, BS · Contact4695094163acastillo17@mgh.harvard.edu
Recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 2024P000780-1
Study chair
Lei Gao, MD
Massachusetts General Hospital
Principal investigator
Kun Hu, PhD
Massachusetts General Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.