NCT06419959 · VA Office of Research and Development
NightWare and Cardiovascular Health in Veterans With PTSD
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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 measures
Change in Pittsburgh Sleep Quality Index
Time frame: Measured before and after 8 weeks of NightWare and sham conditions
Sleep questionnaire with a scale of 0 to 21 with a higher score indicating a significant sleep disturbance
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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;
Exclusion criteria
- 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)
Where
- Aurora, Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 12, 2025 · Source of record for eligibility and locations