Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT04040387
NA

NightWare Randomized Trial 02

Sponsor: NightWare

View on ClinicalTrials.gov

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.

Official title: TNT/NW: Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

270

Start Date

2019-07-24

Completion Date

2025-08-02

Last Updated

2026-04-14

Healthy Volunteers

No

Interventions

DEVICE

NightWare Therapeutic System

A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.

DEVICE

Sham NightWare

NightWare device not providing interventions

Locations (4)

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Minneapolis VA Healthcare System

Minneapolis, Minnesota, United States

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, United States

Ralph H Johnson Veterans Affairs Medical Center

Charleston, South Carolina, United States