NightWare and Cardiovascular Health in Veterans With PTSD

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a special wrist-worn device called NightWare, which is designed to help veterans with post-traumatic stress disorder (PTSD) who experience frequent nightmares. The main goal of the study is to find out if using this device can improve sleep quality and also benefit heart health in veterans who have PTSD. The trial is not yet recruiting participants, but when it starts, it will include veterans aged 22 and older who have a diagnosis of PTSD, struggle with nightmares, and have certain health measurements within a specified range.

To be eligible for the trial, participants should not have unstable medical conditions, such as uncontrolled high blood pressure or active infections, and they should be willing to follow specific rules about using the device. If you join the study, you can expect to use the NightWare device while researchers monitor your sleep and health over time. This trial aims to provide valuable insights into how technology can help improve the lives of veterans dealing with PTSD and its related health issues.

Gender

ALL

Eligibility criteria

• 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)