RecruitingInsomniaPostoperative DeliriumDelayed Neurocognitive Recovery
Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
Eligible age
65+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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).
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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)
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT06375265 · last updated 2026-05-14