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NightWare and Cardiovascular Health in Women With PTSD

NCT07021014 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-06-13

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

NightWare

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.

DEVICE

Sham NightWare

NightWare decive will not deliver an intervention (i.e., no vibration)

Sponsors & Collaborators

  • Ludeman Family Center for Women's Health Research

    collaborator UNKNOWN

  • University of Colorado, Denver

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2028-07-31
Completion
2028-07-31
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 NCT07021014 on ClinicalTrials.gov