PostTraumatic Stress Disorder Clinical Trial
— NWVRCTOfficial title:
A Remote Randomized Double-Blind Sham-Controlled Clinical Trial of NightWare in Adults With Post-Traumatic Stress Disorder and Co-Morbid Nightmare Disorder
NCT number | NCT03934658 |
Other study ID # | NW101004 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 21, 2019 |
Est. completion date | December 15, 2021 |
Verified date | January 2022 |
Source | NightWare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | December 15, 2021 |
Est. primary completion date | December 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - 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. - Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare. Exclusion Criteria - Circadian rhythm disruption on a regular basis (shift-work) - Concurrent presence of prohibited medications - Current use of varenicline - Current use of beta-blockers (unless ophthalmic solutions) - Current use of non-dihydropyridines - Current use of Prazosin for the treatment of nightmares (can include subjects 2 weeks post-taper and discontinuation) - 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 - Self reported pregnancy or intent to become pregnant during the course of the study |
Country | Name | City | State |
---|---|---|---|
United States | RationalPsych | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
NightWare | Center for International Emergency Medical Services, RationalPsych |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to each subsequent 28 day evaluation period | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. This outcome is the difference between the global score on the Pittsburgh Sleep Quality Index (PSQI) score at baseline (Day 0) and average global PSQI score across the post-treatment initiation assessments (Days 14, 28 and every 28 days after that). | 0-730 days |
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