Status:
UNKNOWN
NightWare Open Enrollment Study
Lead Sponsor:
NightWare
Collaborating Sponsors:
RationalPsych
Center for International Emergency Medical Services
Conditions:
PostTraumatic Stress Disorder
Sleep Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Nightmares are a common problem affecting 2-8% of the general population and a higher proportion of clinical populations. The negative consequences of untreated nightmares are significant and include ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03828656
Start Date
February 1 2019
End Date
February 1 2022
Last Update
March 4 2021
Active Locations (1)
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1
RationalPsych
The Bronx, New York, United States, 10461