NightWare Open Enrollment Study
Status unconfirmed · Not applicable
Conditions studied: PostTraumatic Stress Disorder, Sleep Disorder, Stress Disorder, Sleep Initiation and Maintenance Disorders, Combat Disorders, Nightmares Associated With Chronic Post-Traumatic Stress Disorder, Nightmare, Nightmares, REM-Sleep Type
In brief
This study will provide measures 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.
Key facts
- Study ID
- NCT03828656
- Run by
- NightWare
- People needed
- 400
- Starts
- 2019-02-01
- Expected to finish
- 2022-02-01
- Last updated by the study team
- 2021-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- New to NightWare
- Self report of diagnosis with PTSD
- Self-report of PTSD-related repetitive nightmares contributing to disrupted sleep.
- Equal to or older than 18 years of age.
- Proficient in both reading and writing in the English language.
- Pittsburgh Sleep Quality Index (PSQI) score equal to or greater than 10.
- ESS: On question #8 any score above "0" will prompt an additional question:
- Do you drive ("get behind the wheel") when you are drowsy?
- Answer must be "No" to be enrolled in the study for safety.
- Participant owns or has access to devices appropriate for participation in the study including compatible Apple Watch and Apple iPhone.
- Wireless Internet and two power outlets where they sleep.
- OR
- Current NightWare user - Is a participant in current NightWare consumer preference study or has successfully completed any NightWare study protocol.
You may not qualify if…
- New to NightWare
- Circadian rhythm disruption on a regular basis (shift-work)
- Concurrent presence of prohibited diagnoses
- Known diagnosis of OSA
- Diagnosis of an active disorder of arousal from non-rapid eye movement sleep
- Diagnosis of rapid eye movement sleep behavior disorder
- Diagnosis of narcolepsy
- Diagnosis of dementia
- Uncontrolled atrial fibrillation
- Use of Alcohol or Drugs as specified:
- Alcohol Use Disorders Inventory Test (AUDIT) (score of 8 or higher)
- Drug Abuse Screening Test-10 (DAST-10) (score greater than 2)
- Suspicion of nightmares being secondary to substance abuse or withdrawal
- Previous or foreseeable legal proceedings involving nightmares or trauma
- Nocturia that causes awakening from sleep
- Known sleep walking
- Acting out of dreams PRIOR to PTSD trauma
- Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare.
- OR
- Current NightWare User
- No known adverse reaction to the use of the NightWare system.
Where it is running
- RationalPsych — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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