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NCT03934658 · ClinicalTrials.gov registry record · NA

Remote Study of NightWare for PTSD With Nightmares

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

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

NCT03934658 is a NA study of Posttraumatic Stress Disorder and Sleep Disorder that has completed, run by NightWare. The registered enrollment target is 81 participants, below the 111-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03934658, a NA study of Posttraumatic 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.

Conditions Studied

Posttraumatic 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

Sponsor

NightWare

3 total trials

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What the Registry Record Tells You About NCT03934658

The ClinicalTrials.gov registry entry for NCT03934658 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 111-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (27% lower). The listed sponsor is NightWare, which has 3 total studies on file at ClinicalTrials.gov.

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

NCT03934658 reports 1 study location spanning 1 distinct geographic area - top geographies include 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: Posttraumatic 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.