NightWare and Cardiovascular Health in Veterans With PTSD

Part of paid clinical trials in Aurora, Colorado.

Sponsor
VA Office of Research and Development
Study ID
NCT06419959
Status
Recruiting
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Conditions

  • Autonomic Dysfunction
  • Cardiovascular Diseases
  • Endothelial Dysfunction
  • Nightmare
  • Post-traumatic Stress Disorder (PTSD)
  • Vascular Stiffness
  • Veteran

Eligibility Criteria

Sex
ALL
Age
22 Years - 88 Years
Healthy Volunteers
Accepted

Interventions

  • NightWare — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 10, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NightWare active
    Intervention with NightWare Therapeutic System
  • Sham Comparator: NightWare Sham
    NightWare app disabled; device will not deliver an intervention

Primary Outcome Measure

Change in Pittsburgh Sleep Quality Index [ Time Frame: Measured before and after 8 weeks of NightWare and sham conditions ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rocky Mountain Regional VA Medical Center, Aurora, COAuroraColorado80045-7211
Claire Cox, BS
[email protected]
303-372-1396
Kerrie L Moreau, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Rocky Mountain Regional VA Medical Center, Aurora, CO· Aurora, CO

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