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Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Recruiting
65 years and older
All
Phase N/A

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Overview

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).

Description

CBT-I is the frontline treatment for insomnia but is not considered for preoperative care of older surgical patients with insomnia who are at risk of perioperative neurocognitive disorders associated with sleep/circadian dysfunction. We propose to determine if digital CBT-I (dCBT-I) is feasible for treating older surgical patients with insomnia symptoms and to examine the effects of dCBT-I on sleep, cognitive trajectory, mood, pain, activity, and function after surgery. 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 CBT-I mobile application paired with a wearable device (wrist actigraphy).

Eligibility

Inclusion Criteria:

  1. Adults ≥ 65 years old
  2. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip) with an anticipated stay of ≥48 hours
  3. At least mild insomnia (ISI score of ≥10 on telephone screening)
  4. Stable sleep-affecting medications in the prior month (by clinical review)
  5. Own a smart phone
  6. Willingness to use the dCBT-I app and actigraphy.

Exclusion Criteria:

  1. Current or previous CBT-I
  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)

Study details
    Insomnia
    Postoperative Delirium
    Delayed Neurocognitive Recovery
    Postoperative Neurocognitive Disorder

NCT06375265

Massachusetts General Hospital

23 May 2025

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