Actively Recruiting
Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
Led by Massachusetts General Hospital · Updated on 2026-05-14
50
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 65 years old or older
- Scheduled for elective orthopedic total joint replacement surgery (knee or hip)
- Have at least mild insomnia (Insomnia Severity Index score of 10 or higher)
- Own a smartphone
- Willing to use the digital CBT-I app and wrist actigraphy device
You will not qualify if you...
- Received cognitive behavioral therapy for insomnia in the last 6 months
- Have rapidly progressive illnesses with life expectancy less than 6 months
- Have active psychosis or suicidal thoughts
- Work irregular shifts or have irregular sleep patterns
- Have moderate to severe sleep apnea without compliant CPAP use
- Have sleep disorders other than insomnia or apnea
- Have a diagnosis of dementia or cognitive impairment
- Started, stopped, or changed dose of sleep-affecting medications within one month before or during the study unless stable
- Have no surgery planned within 12 months after consent; eligibility reassessed if surgery delayed more than 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Andrea Castillo, BS
CONTACT
M
Mili Jimenez Gallardo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here