A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)
Sponsor: Massachusetts General Hospital
Trial Details
| Condition | Insomnia, Postoperative Delirium, Delayed Neurocognitive Recovery, Postoperative Neurocognitive Disorder |
| Intervention | digital Cognitive Behavioral Therapy for Insomnia (dCBT-I); Sleep Health Education |
| Phase | NA |
| Status | Recruiting |
| Participants | 50 |
| Est. Completion | 30 Sept 2026 |
| Last Updated | 14 May 2026 |
Primary Outcome
Adherence; Insomnia Severity
Eligibility Criteria
Inclusion 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 consented, eligibility will be reassessed if surgery is delayed by more than 3 months
Trial Sites
Countries
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