Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
NCT ID: NCT06375265
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2025-01-15
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
NCT05991492
Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners
NCT06250725
SleepUp Digital CBTi-based Platform for Insomnia
NCT04949360
Improving Sleep for Healthy Hearts
NCT02848859
Deep Sleep in Older Adults
NCT07316153
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Sleep Health Education
Preoperative sleep health education materials
Sleep Health Education
Sleep Health Education materials provided
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Sleep Health Education
Sleep Health Education materials provided
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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) without CPAP compliance per chart review
6. Sleep disorders other than insomnia or apnea
7. Cognitive impairment (diagnosis of dementia)
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lei Gao, MBBS, MMSc
Assistant Professor of Anaesthesia
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lei Gao, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024P000780-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.