Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (NCT06375265) | Clinical Trial Compass
RecruitingNot Applicable
Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
United States50 participantsStarted 2025-01-15
Plain-language 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).
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults ≥ 65 years old
. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip)
. At least mild insomnia (ISI score of ≥10 on telephone screening or RedCap screening questionnaire)
Exclusion criteria
. Current or previous CBT-I exposure in the last 6 months prior to the start of the study
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adherence: CBT-I
Timeframe: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.
2
Adherence: Sleep Diary/Actigraphy
Timeframe: Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery.
3
Adherence: Homework Completion
Timeframe: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.
4
Insomnia Severity
Timeframe: At screening, baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery
. Moderate-severe sleep apnea (apnea/hypopnea index ≥15) without CPAP compliance per chart review
. Sleep disorders other than insomnia or apnea
. Cognitive impairment (diagnosis of dementia)
. 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)