Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
Recruiting now · Not applicable
Conditions studied: Insomnia, Postoperative Delirium, Delayed Neurocognitive Recovery, Postoperative Neurocognitive Disorder
In brief
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).
Key facts
- Study ID
- NCT06375265
- Run by
- Massachusetts General Hospital
- People needed
- 50
- Starts
- 2025-01-15
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-05-14
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You 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 may not qualify 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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