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NCT03934658 · ClinicalTrials.gov registry record · NA

Remote Study of NightWare for PTSD With Nightmares

A NA study of Post Traumatic Stress Disorder and Sleep Disorder, sponsored by NightWare.

Completed
Registry status
NA
Development phase
81
Enrollment target
1
Study location

NCT03934658: Completed NA study of Post Traumatic Stress Disorder and Sleep Disorder, sponsored by NightWare.

NCT03934658 is a NA study of Post Traumatic Stress Disorder and Sleep Disorder that has completed, run by NightWare. The registered enrollment target is 81 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03934658, a NA study of Post Traumatic Stress Disorder and Sleep Disorder, has completed, sponsored by NightWare.

COMPLETED
Registry status
NA
Development phase
81 participants
Enrollment target
1
Study location

Study 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.

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

Conditions Studied

Post Traumatic Stress Disorder Sleep Disorder Sleep Initiation and Maintenance Disorders Nightmare Combat Disorders Stress Disorder Nightmares Associated With Chronic Post-Traumatic Stress Disorder Nightmares, REM-Sleep Type

Interventions

  • DEVICE NightWare Therapeutic System
  • DEVICE NightWare Therapeutic System in Sham Mode

Study Locations (1)

New York

  • RationalPsych - The Bronx

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2019-05-21
Est. Completion 2021-12-15
Phase NA
NightWare

3 total trials

What the finished NCT03934658 record still lists

NCT03934658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (88% lower).

The record links to 8 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which NightWare Therapeutic System is the first listed.

NCT03934658 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT03934658 about?

NCT03934658 is a clinical study titled "Remote Study of NightWare for PTSD With Nightmares". 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 slee...

What is the current status of trial NCT03934658?

This trial is currently completed. It is a NA study. The enrollment target is 81 participants. The study started on 2019-05-21. Estimated completion is 2021-12-15.

What conditions does trial NCT03934658 study?

This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Sleep Disorder, Sleep Initiation and Maintenance Disorders, Nightmare, Combat Disorders.

What interventions are being tested in trial NCT03934658?

The interventions under investigation include: NightWare Therapeutic System (DEVICE), NightWare Therapeutic System in Sham Mode (DEVICE).

Who is sponsoring clinical trial NCT03934658?

This trial is sponsored by NightWare, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03934658 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Post Traumatic Stress Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03934658's enrollment target sits among peer trials

81 131st of 262 higher than 129 of 262 other Post Traumatic Stress Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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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Related registry views

Source: ClinicalTrials.gov NCT03934658, the US trial registry maintained by the National Library of Medicine. NCT03934658 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.