NCT06375265 Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
| NCT ID | NCT06375265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2026-09-30 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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. Starting sleep-affecting medications less than a month prior to starting study or at any time during the study period; not excluded if stable sleep-affecting medications in the prior month (by clinical review) 9. No surgery within 12 months of con
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