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NCT04040387 · ClinicalTrials.gov registry record · NA
NightWare Randomized Trial 02
A NA study, sponsored by NightWare.
- Completed
- Registry status
- NA
- Development phase
- 270
- Enrollment target
NCT04040387: Completed NA study, sponsored by NightWare.
NCT04040387 is a NA study that has completed, run by NightWare. The registered enrollment target is 270 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04040387, a NA study, has completed, sponsored by NightWare.
- COMPLETED
- Registry status
- NA
- Development phase
- 270 participants
- Enrollment target
Study Summary
This study will provide preliminary estimates 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.
Primary Outcome
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 sc
Interventions
- DEVICE Sham NightWare
- DEVICE NightWare Therapeutic System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2019-07-24 |
| Est. Completion | 2025-08-02 |
| Phase | NA |
What the finished NCT04040387 record still lists
NCT04040387 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham NightWare is the first listed.
NCT04040387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04040387 about?
NCT04040387 is a clinical study titled "NightWare Randomized Trial 02". This study will provide preliminary estimates 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 ...
What is the current status of trial NCT04040387?
This trial is currently completed. It is a NA study. The enrollment target is 270 participants. The study started on 2019-07-24. Estimated completion is 2025-08-02.
What interventions are being tested in trial NCT04040387?
The interventions under investigation include: Sham NightWare (DEVICE), NightWare Therapeutic System (DEVICE).
Who is sponsoring clinical trial NCT04040387?
This trial is sponsored by NightWare, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04040387's enrollment target sits among peer trials
270 387th of 2000 higher than 1,609 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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