NightWare Randomized Trial 02

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.

Conditions

• Stress Disorders, Post-Traumatic
• Combat Disorders
• Ptsd
• Nightmare
• Nightmares, REM-Sleep Type
• Nightmare 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

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center

  collaborator FED

• Louis Stokes VA Medical Center

  collaborator FED

• Walter Reed National Military Medical Center

  collaborator FED

• Ralph H. Johnson VA Medical Center

  collaborator FED

• NightWare

  lead INDUSTRY

Principal Investigators

• Daniel R Karlin, MD MA · NightWare

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-24

Primary Completion

2025-05-31

Completion

2025-08-02

FDA Device

Yes

Countries

• United States

Study Locations