Digital sleep optimization for older surgical patients
A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)
This study is testing if a digital sleep program can help older patients sleep better and think clearer after major joint surgery compared to regular sleep education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06375265 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the feasibility of using a digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) application, combined with a wearable device, to improve sleep and cognitive outcomes in older patients undergoing major orthopedic joint surgery. The study aims to address insomnia symptoms in patients aged 65 and older, who are at risk for postoperative neurocognitive disorders. Participants will be randomized to receive either the dCBT-I intervention or sleep health education, with outcomes measured in terms of sleep quality, cognitive function, mood, pain, activity, and overall recovery post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 and older scheduled for elective orthopedic total joint replacement with mild insomnia.
Not a fit: Patients with severe sleep apnea, cognitive impairment, or those who have previously undergone CBT-I may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance postoperative recovery and cognitive health in older surgical patients suffering from insomnia.
How similar studies have performed: Previous studies have shown that digital CBT-I can be effective for insomnia, suggesting potential success for this novel application in a surgical population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Lei Gao, MD — Massachusetts General Hospital
- Study coordinator: Andrea Castillo, BS
- Email: acastillo17@mgh.harvard.edu
- Phone: 4695094163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.