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Recruiting NCT06375265

Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

No phase Interventional Insomnia Postoperative Delirium Delayed Neurocognitive Recovery Postoperative Neurocognitive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I), Sleep Health Education.
Who it may be relevant to
Registry conditions: Insomnia, Postoperative Delirium, Delayed Neurocognitive Recovery, Postoperative Neurocognitive Disorder. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)

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).

Detailed 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).

Interventions

  • Behavioral digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
    Preoperative hybrid intervention (in-person or via phone/video) over 4 weeks, and at 2 weeks, and 1 month after surgery using content from the CBT-I Coach app from Veteran Affairs.
  • Behavioral Sleep Health Education
    Sleep Health Education materials provided

Primary outcome measures

  • Adherence: CBT-I [Time frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.]
  • Adherence: Sleep Diary/Actigraphy [Time frame: Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery.]
  • Adherence: Homework Completion [Time frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.]
  • Insomnia Severity [Time frame: At screening, baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery]
Secondary outcome measures (10)
  • Sleep Quality [Time frame: At baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery]
  • Utility [Time frame: After dCBT-I intervention during Review session ~1 day to 1 week before surgery.]
  • Satisfaction with intervention [Time frame: After dCBT-I intervention during Review session ~1 days to 1 week before surgery.]
  • Cognition [Time frame: At baseline and 2 weeks, 1- and 3-months after surgery]
  • Pain severity and Function [Time frame: At baseline, end of the dCBTI/control intervention pre-surgery and 2 weeks, 1- and 3-months after surgery]
  • Mood/Anxiety [Time frame: At baseline and 1- and 3-months after surgery]
  • Postoperative Delirium Incidence [Time frame: From postoperative day 1 to postoperative day 3]
  • Postoperative Delirium Severity [Time frame: From postoperative day 1 to postoperative day 3]
  • Delayed Neurocognitive Recovery [Time frame: At 1-months after surgery]
  • Postoperative Neurocognitive Disorders (NCD) [Time frame: At 3-months after surgery]

Eligibility criteria

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)

5\. Own a smart phone 6. Willingness to use the dCBT-I app and actigraphy.

Exclusion criteria

  • Current or previous CBT-I exposure in the last 6 months prior to the start of the study
  • Rapidly progressive illnesses/life expectancy <6 months
  • Active psychosis/suicidal ideation
  • Irregular shift work/sleep patterns
  • 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)
  • No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Publications

  • Charles AE, Castillo Suarez AA, Chhajed M, Jimenez Gallardo M, Sanchez Valdes K, Li P, Hu K, Wong PM, Winkelman J, Gao L. Perioperative sleep optimisation and brain health in older adults (SLEEP-BOOST): protocol for a randomised controlled trial. BMJ Open. 2026 May 28;16(5):e116526. doi: 10.1136/bmjopen-2026-116526. PMID 42209013

Identifiers

NCT: NCT06375265 · 2024P000780-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗