Recruiting

NightWare

Sponsor:

VA Office of Research and Development

Code:

NCT06419959

Conditions

Post-traumatic Stress Disorder (PTSD)

Cardiovascular Diseases

Autonomic Dysfunction

Vascular Stiffness

Nightmare

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Interventions

NightWare

Study Details

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

Study ID

NCT06419959

Start date

Sep 10, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 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).
2. Self-report having repetitive nightmares contributing to disrupted sleep;
3. Age 22 years (rationale is because the device has only been used in adults in 22 years and older);
4. Resting blood pressure (BP, <160/100 mmHg);
5. Fasted glucose <126 mg/dL;
6. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher;
7. 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;
8. Wireless Internet and two power outlets in sleeping location;
9. Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare;

Exclusion Criteria:

1. Unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer);
2. Active infection (note, anyone with an active infection would become eligible once the infection has ended);
3. 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;
4. Use of insulin or sulfonylureas
5. Pregnancy or currently breast feeding;
6. 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;
7. 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 \[C-SSRS\]).
8. Shift workers (due to circadian rhythm disruption);
9. Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy;
10. Nocturia that causes awakening from sleep;
11. Known sleep walking or acting out dreams (contraindication to NW use);
12. Diagnosis or suspicion of dementia;
13. Seizure disorder
14. Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NightWare active

Intervention with NightWare Therapeutic System

sham comparator: NightWare Sham

NightWare app disabled; device will not deliver an intervention

Interventions

NightWare

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045-7211

Contacts

Principal Investigator:

Kerrie L Moreau, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-09-12.