Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Description

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).

Conditions

Insomnia, Postoperative Delirium, Delayed Neurocognitive Recovery, Postoperative Neurocognitive Disorder

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Study Overview

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Study Details

Study 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).

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

Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Condition
Insomnia
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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) per chart review
  • 6. Sleep disorders other than insomnia or apnea
  • 7. Cognitive impairment (diagnosis of dementia)

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Lei Gao, MD, PRINCIPAL_INVESTIGATOR, Mass. General Hospital

Study Record Dates

2026-08-31