Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06375265
Status
Recruiting
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Conditions

  • Delayed Neurocognitive Recovery
  • Insomnia
  • Postoperative Delirium
  • Postoperative Neurocognitive Disorder

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) — BEHAVIORAL
    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.
  • Sleep Health Education — BEHAVIORAL
    Sleep Health Education materials provided

Study Details

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).

Key Dates

Start date
Jan 15, 2025
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital CBT-I
    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.
  • Active Comparator: Sleep Health Education
    Preoperative sleep health education materials

Primary Outcome Measure

Adherence: CBT-I [ Time Frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Lei Gao, MD
[email protected]
6178882941
Andrea Castillo, BS
[email protected]
4695094163

Find similar trials in Boston, MA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Massachusetts General Hospital· Boston, MA

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