Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)

NAEnrolling by invitationINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

July 24, 2019

Primary Completion Date

August 24, 2024

Study Completion Date

August 24, 2024

Conditions
Stress Disorders, Post-TraumaticCombat DisordersPtsdNightmareNightmares, REM-Sleep TypeNightmare Disorder With Associated Non-Sleep Disorder
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

Trial Locations (4)

20814

Walter Reed National Military Medical Center, Bethesda

22060

Fort Belvoir Community Hospital, Fort Belvoir

44106

Louis Stokes Cleveland VA Medical Center, Cleveland

55417

Minneapolis VA Healthcare System, Minneapolis

All Listed Sponsors
collaborator

Minneapolis Veterans Affairs Medical Center

FED

collaborator

Louis Stokes VA Medical Center

FED

collaborator

Walter Reed National Military Medical Center

FED

collaborator

Fort Belvoir Community Hospital

FED

lead

NightWare

INDUSTRY