Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)
Massachusetts General Hospital
50 participants
Jan 15, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria9
- 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
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Interventions
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 materials provided
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06375265