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Digital sleep program for older adults having joint surgery, studying insomnia and brain health

Tests a phone-based insomnia program in older adults having major joint surgery.

Key facts

Who runs it
Massachusetts General Hospital
Where
Boston, United StatesSee the site
Trial code
Registry title
Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
Status
Recruiting
People taking part
50 people, planned
Started
15 Jan 2025
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
  • Sleep Health Education
Record updated
14 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 65 or older with at least mild insomnia who are scheduled for a planned knee or hip replacement. It tests a sleep therapy phone app with a wrist sleep tracker.

Age
65 years and older
Sex
All sexes
Disease stage
At least mild insomnia (ISI score of ≥10 on screening). Scheduled for a planned total knee or hip replacement.
Earlier treatment
No cognitive behavioral therapy for insomnia (CBT-I) now or in the last 6 months before the study.

Main reasons for not taking part

  • Fast-worsening illness or life expectancy under 6 months
  • Active psychosis or thoughts of suicide
  • Irregular shift work or sleep patterns, or sleep disorders other than insomnia or apnea
  • Moderate-severe sleep apnea (apnea/hypopnea index ≥15) without regular CPAP use
  • Dementia, or starting, stopping or changing sleep-affecting prescription medicines within 1 month before the study or during it

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

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

Who cannot take part

  • Current or previous CBT-I exposure in the last 6 months prior to the start of the study
  • 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
  • Rapidly progressive illnesses/life expectancy <6 months
  • Sleep disorders other than insomnia or apnea
  • Cognitive impairment (diagnosis of dementia)
  • Active psychosis/suicidal ideation
  • Irregular shift work/sleep patterns
  • Moderate-severe sleep apnea (apnea/hypopnea index ≥15) without CPAP compliance per chart review

Where in United States

  • Massachusetts General HospitalBoston, United StatesContact: Lei Gao, MDTaking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Digital CBT-ITreatment being tested

    Preoperative digital CBT-I with the CBT-I Coach app for up to 4 weekly sessions and postoperative booster sessions at 2 weeks and 1 month after surgery.

    Treatment: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)

  • Sleep Health EducationExisting treatment, for comparison

    Preoperative sleep health education materials

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)
Plain-language title
Digital sleep program for older adults having joint surgery, studying insomnia and brain healthGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Publications
Record updated
14 September 2026