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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-01-15 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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) 9. No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months
Contact & Investigator
Lei Gao, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06375265 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06375265 currently recruiting?
Yes, NCT06375265 is actively recruiting participants. Contact the research team at acastillo17@mgh.harvard.edu for enrollment information.
Where is the NCT06375265 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06375265 clinical trial?
NCT06375265 is sponsored by Massachusetts General Hospital. The principal investigator is Lei Gao, MD at Massachusetts General Hospital. The trial plans to enroll 50 participants.
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