RecruitingNot ApplicableNCT06419959

NightWare and Cardiovascular Health in Veterans With PTSD

Improving Cardiovascular Health in Veterans With PTSD by Treating Trauma-Related Nightmares With NightWare


Sponsor

VA Office of Research and Development

Enrollment

125 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Summary

The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.


Eligibility

Min Age: 22 YearsMax Age: 88 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a smartwatch app called NightWare can reduce nightmares and improve sleep — and whether better sleep helps protect heart health — in veterans with PTSD. The app detects nightmares and gently vibrates to interrupt them without fully waking you up. **You may be eligible if...** - You are a veteran aged 22 or older with a PTSD diagnosis - You have frequent nightmares that disrupt your sleep - Your resting blood pressure is below 160/100 - Your fasting blood sugar is below 126 mg/dL - You have poor sleep quality (score 6 or higher on a standard sleep test) - You do not drive when drowsy - You can connect a device to WiFi **You may NOT be eligible if...** - You do not have PTSD or do not experience nightmares - Your blood pressure or blood sugar is too high - You drive when feeling sleepy - You cannot use wireless technology Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENightWare

Nightware intervention app (enabled) will attempt to detect when an individual is having a nightmare based on a Nightware proprietary algorithm and attempt to disrupt the nightmare without awakening. In the sham comparator group the NightWare app will be disabled and not deliver an intervention.


Locations(1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

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NCT06419959