About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Self-report having repetitive nightmares contributing to disrupted sleep
Resting blood pressure (BP, <160/100 millimeters of mercury (mmHg)
Fasted glucose <126 milligrams per deciliter (mg/dL)
Disqualifiers
Unstable medical condition (e.g., uncontrolled hypertension or active Cardiovascular disease (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 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
Use of insulin or sulfonylureas
Trial design
Parallel
Treatments tested in this trial
NightWare
DeviceNightware 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Pittsburgh Sleep Quality Index
Sleep questionnaire with a scale of 0 to 21 with a higher score indicating a significant sleep disturbance
Secondary outcomes
Change in physiological sleep - total sleep time
Total sleep duration (minutes) calculated through ambulatory electroencephalography.
Change in endothelial function
Brachial artery flow mediated dilation (FMD) using ultrasound
Change in Autonomic function - spontaneous baroreflex sensitivity (BRS)
Cardiovagal baroreflex sensitivity (cBRS) measured using beat-to-beat time series of systolic blood pressures (finger photo-plethysmography) and R-R interval (three-lead electrocardiogram) will be recorded simultaneously at 1,000 Hz.
Change in large elastic artery stiffness
Carotid-femoral pulse wave velocity (PWV)
Sponsors and contacts
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