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Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)

NCT03795987 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-02-26

No results posted yet for this study

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.

Sponsors & Collaborators

  • Minneapolis Veterans Affairs Medical Center

    collaborator FED

  • NightWare

    lead INDUSTRY

Principal Investigators

  • Daniel R Karlin, MD MA · NightWare

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2019-08-14
Completion
2019-08-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03795987 on ClinicalTrials.gov