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NightWare and Cardiovascular Health in Adults With PTSD

NCT05365607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-08

No results posted yet for this study

Summary

The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular aging and autonomic function in adults with nightmares related to PTSD.

Conditions

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Kerrie Moreau, PhD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-24
Primary Completion
2024-08-15
Completion
2024-08-18
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 NCT05365607 on ClinicalTrials.gov