Status:
COMPLETED
Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia
Lead Sponsor:
Northeastern University
Collaborating Sponsors:
Edith Nourse Rogers Memorial Veterans Hospital
Conditions:
Chronic Insomnia
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
Veterans of the most recent wars in Afghanistan and Iraq (collectively, post 9/11 Veterans) have notable sleep problems including chronic insomnia. Here, the investigators plan to compare two groups o...
Detailed Description
To determine if the addition of physical activity (PA) to (CBTI) can further enhance sleep, physical activity, functioning, or social engagement over and above self-management use of a CBTI app alone,...
Eligibility Criteria
Inclusion
- Eligible individuals will be US military Veterans
- Eligible veterans will have served in the military during the post-9/11 period
- Eligible veterans will have chronic, functionally impairing insomnia (i.e., at baseline veterans must have an Insomnia Severity Index score \> 10 with insomnia duration of at least 1 month, and impaired daytime functioning.
- Eligible individuals must be willing to use devices (e.g., Fitbit, WatchPAT)provided by the study team.
- Eligible individuals may have mild or moderate obstructive sleep apnea (as determined by one out of either of two nights with a WatchPAT-based Apnea-Hypopnea Index \[AHI\] \<= 30 events/hour of sleep).
Exclusion
- Periodic leg movements
- Circadian rhythm disorder
- Use of medications or health issues (e.g., permanent pacemaker, sustained non-sinus cardiac arrhythmias, finger deformity, etc.) that would interfere with the use of the WatchPAT sleep monitor
- Severe obstructive sleep apnea (as determined by one out of either of two nights with a WatchPAT-based Apnea-Hypopnea Index \[AHI\] \> 30 events/hour of sleep)
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03305354
Start Date
January 31 2018
End Date
June 27 2019
Last Update
August 20 2019
Active Locations (1)
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1
Edith Nourse Rogers Memorial VA Hospital
Bedford, Massachusetts, United States, 01730