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โ† Trials
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Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

RecruitingNAAges 65 Years - anyAllMassachusetts General Hospital
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Adults โ‰ฅ 65 years old 2. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip) 3. At least mild insomnia (ISI score of โ‰ฅ10 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 โ‰ฅ15) 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
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What it tests

  • digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
  • Sleep Health Education
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Where

1 site
Massachusetts General Hospital
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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