NightWare for reducing nightmares and supporting heart health in Veterans with PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Veterans with DSM-5 PTSD who report repetitive nightmares and poor sleep will use the prescription NightWare wrist-wearable during sleep while researchers monitor outcomes. Sleep measures will include nightmare frequency and validated questionnaires, and cardiovascular assessments will include vascular stiffness, autonomic function, blood pressure, and relevant biomarkers. The study enrolls adults 22 and older with controlled blood pressure and glucose who can run the device at home with wireless internet and power. Safety, adherence, and device-collected heart-rate patterns will also be tracked over the intervention period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of Post-traumatic stress disorder (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. Resting blood pressure (BP, \<160/100 millimeters of mercury (mmHg)
4. Fasted glucose \<126 milligrams per deciliter (mg/dL)
5. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher
6. 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
7. Wireless Internet and two power outlets in sleeping location
8. 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 Cardiovascular disease (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 thyroid stimulating hormone (TSH)\<0.5 or \>5.0 milliunits per liter (mU/L); volunteers with abnormal thyroid stimulating hormone (TSH) values will be re-considered for participation in the study after follow-up evaluation by the Primary Care Provider (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 NightWare (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)

Where it's running

• Rocky Mountain Regional VA Medical Center, Aurora, CO
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Kerrie L Moreau, PhD — Rocky Mountain Regional VA Medical Center, Aurora, CO
• Study coordinator: Kerrie L Moreau, PhD
• Email: Kerrie.Moreau@va.gov
• Phone: (720) 885-1950

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.