NightWare Open Enrollment Study (NCT03828656) | Clinical Trial Compass
UnknownNot Applicable
NightWare Open Enrollment Study
United States400 participantsStarted 2019-02-01
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
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 se…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is using the Pittsburgh Sleep Quality Index to measure sleep improvement every 28 days — can you help me understand what a meaningful change on that scale would actually look like for someone with my level of PTSD-related nightmares?
2Since this trial is listed as 'Phase NA' and its recruitment status is unknown, does that mean the evidence on how well NightWare works is still limited, and should I be cautious about treating it as a proven option right now?
3NightWare seems to be a wearable device-based approach for nightmare and sleep disruption in PTSD — before I consider this, are there existing treatments like image rehearsal therapy or medications that have stronger evidence I should try first?
4Given that the trial focuses on combat-related and chronic PTSD nightmares specifically, does my own diagnosis and history fit closely enough with what this study is designed for to make the results potentially relevant to me?
5Because the recruitment status is unclear, can you help me find out whether this study is still actively enrolling, and if not, whether there are similar trials or ways to access NightWare outside of a research setting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to each subsequent 28 day evaluation period