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Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

NCT06375265 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-14

No results posted yet for this study

Summary

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

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

Sponsors & Collaborators

Principal Investigators

  • Lei Gao, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06375265 on ClinicalTrials.gov