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Recruiting
NCT06375265
Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
Conditions: Insomnia, Postoperative Delirium, Delayed Neurocognitive Recovery, Postoperative Neurocognitive Disorder
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
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 \
Source: ClinicalTrials.gov (NCT06375265). StuddyBuddy aggregates publicly available trial information.
