NightWare and Cardiovascular Health in Women With PTSD

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07021014
Status
Not Yet Recruiting

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Conditions

  • Autonomic Dysfunction
  • Cardiovascular Diseases
  • Endothelial Dysfunction
  • Kidney Diseases
  • Nightmare
  • Post Traumatic Stress Disorder
  • Renal Dysfunction
  • Trauma and Stressor Related Disorders
  • Vascular Stiffness

Eligibility Criteria

Sex
FEMALE
Age
22 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • NightWare — DEVICE
    A wearable digital therapeutic platform consisting of an Apple Watch and iPhone pre-provisioned with Nightware intervention app that will deliver a mild vibration to the watch after detecting individual having a nightmare based on Nightware proprietary algorithm, arousing the individual and disrupting nightmare without awakening.
  • Sham NightWare — DEVICE
    NightWare decive will not deliver an intervention (i.e., no vibration)

Study Details

The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.

Key Dates

Start date
Jul 31, 2025
Status verified
Jun 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

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

Arms

  • Experimental: Experimental NightWare
    In women with PTSD-related nightmares randomized to the active condition, when the stress index is reached during sleep, NightWare will intervene with varying degrees of vibratory stimulation to the watch over a variable length of time to arouse the person out of the nightmare without awakening.
  • Sham Comparator: Sham NightWare
    In women with PTSD-related nightmares randomized to the sham condition, the NightWare intervention will not be enabled
  • No Intervention: Control Women without PTSD-related Nightmares
    Age-matched women without PTSD-related nightmares will complete baseline testing only (no intervention).

Primary Outcome Measure

Brachial artery flow-mediated dilation (FMD) [ Time Frame: PTSD vs controls at baseline. In PTSD group only, change with NightWare vs Sham (measured before and after 8 weeks of NightWare or sham conditions). ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Emily A Larson, PhD
[email protected]
720-523-3224
University of Colorado CCTSI CTRCDenverColorado80045
Emily Larson, PhD
[email protected]
720-523-3224

Find similar trials in Aurora, CO

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Colorado Anschutz Medical Campus· Aurora, COUniversity of Colorado CCTSI CTRC· Denver, CO

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