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Summary
This study will provide preliminary estimates of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.
Official title: TNT/NW: Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2019-07-24
Completion Date
2025-08-02
Last Updated
2026-04-14
Healthy Volunteers
No
Conditions
Interventions
NightWare Therapeutic System
A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.
Sham NightWare
NightWare device not providing interventions
Locations (4)
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Minneapolis VA Healthcare System
Minneapolis, Minnesota, United States
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States
Ralph H Johnson Veterans Affairs Medical Center
Charleston, South Carolina, United States