CompletedNot Applicable

Remote Study of NightWare for PTSD With Nightmares

United States81 participantsStarted 2019-05-21

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 * 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 * Uncontroll…

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to each subsequent 28 day evaluation period

Timeframe: 0-730 days

Trial details

NCT IDNCT03934658

SponsorNightWare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-15

View on ClinicalTrials.gov More PostTraumatic Stress Disorder trials