NightWare and Cardiovascular Health in Veterans With PTSD

NCT06419959 | Recruiting DMC FDA Device

• 3 other identifiers: CARB-005-23FCX002762-01A124-0284
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Sleep; Oxidative stress; aging, inflammation; sex/gender; Veteran; Trauma and Stressor Related Disorders; Mental Disorders; Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Cardiovascular Diseases; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• Change in Pittsburgh Sleep Quality Index

  Sleep questionnaire with a scale of 0 to 21 with a higher score indicating a significant sleep disturbance

  Measured before and after 8 weeks of NightWare and sham conditions

Secondary Outcomes (11)

• Change in physiological sleep - total sleep time

  Measured before and after 8 weeks of NightWare and sham conditions

• Change in endothelial function

  Measured before and after 8 weeks of NightWare and sham conditions

• Change in Autonomic function - spontaneous baroreflex sensitivity (BRS)

  Measured before and after 8 weeks of NightWare and sham conditions

• Change in large elastic artery stiffness

  Measured before and after 8 weeks of NightWare and sham conditions

• Change in large elastic artery stiffness

  Measured before and after 8 weeks of NightWare and sham conditions

Study Arms (2)

NightWare active

EXPERIMENTAL

Intervention with NightWare Therapeutic System

Device: NightWare

NightWare Sham

SHAM COMPARATOR

NightWare app disabled; device will not deliver an intervention

Device: NightWare

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.

NightWare Sham; NightWare active

Eligibility Criteria

• Age: 22 Years - 88 Years
• Gender Eligibility Details: All genders
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
• Self-report having repetitive nightmares contributing to disrupted sleep;
• Age 22 years (rationale is because the device has only been used in adults in 22 years and older);
• Resting blood pressure (BP, \<160/100 mmHg);
• Fasted glucose \<126 mg/dL;
• Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher;
• Epworth Sleepiness Scale (ESS): Question #8 score above "0" will prompt an additional question: Do you drive ("get behind the wheel") when you are drowsy? The answer must be "No" to be enrolled in the study due to safety concerns;
• Wireless Internet and two power outlets in sleeping location;
• Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare;

You may not qualify if:

• Unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer);
• Active infection (note, anyone with an active infection would become eligible once the infection has ended);
• Thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement; or other problems that would interfere with participation in the study;
• Use of insulin or sulfonylureas
• Pregnancy or currently breast feeding;
• Current history (past 3 months) of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate;
• Participants will be excluded if they report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the Columbia-Suicide Severity Rating Scale \[C-SSRS\]).
• Shift workers (due to circadian rhythm disruption);
• Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy;
• Nocturia that causes awakening from sleep;
• Known sleep walking or acting out dreams (contraindication to NW use);
• Diagnosis or suspicion of dementia;
• Seizure disorder
• Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Cardiovascular Diseases; Primary Dysautonomias; Inflammation; Trauma and Stressor Related Disorders; Mental Disorders; Nervous System Diseases; Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kerrie L Moreau, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerrie L Moreau, PhD

CONTACT

(720) 885-1950; Kerrie.Moreau@va.gov

Claire Cox, BS

CONTACT

(303) 372-1396; claire.cox@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo (i.e., sham intervention) controlled parallel proof-of-concept study

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 17, 2024
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)