Remote Study of NightWare for PTSD With Nightmares

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

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

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

NightWare Therapeutic System in Sham Mode

A wearable digital therapeutic system that will measure physiologic data when worn during sleep that does not deliver interventions.

Sponsors & Collaborators

• RationalPsych

  collaborator UNKNOWN

• Center for International Emergency Medical Services

  collaborator OTHER

• NightWare

  lead INDUSTRY

Principal Investigators

• Daniel R Karlin, MD MA · RationalPsych

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-21

Primary Completion

2021-12-15

Completion

2021-12-15

FDA Device

Yes

Countries

• United States

Study Locations