Studying NightWare Wrist Device to Improve Sleep and Heart Health in Veterans With PTSD Nightmares

What this Trial Is About

Researchers are investigating the impact of NightWare, a prescription wrist-wearable device, on improving sleep quality and cardiovascular health in Veterans suffering from posttraumatic stress disorder PTSD with trauma-related nightmares. PTSD is linked to serious health issues including cardiovascular disease, which is the leading cause of death in U.S. adults. Nightmares significantly disrupt sleep and daily functioning, and are also linked to cardiovascular risks. Existing treatments often leave residual symptoms, and access to care can be limited, highlighting the need for alternative therapies like NightWare. The study involves two groups one using the active NightWare device, which detects nightmare distress through biometric data and attempts to interrupt the nightmare without waking the user, and a sham group where the devices app is disabled. Participants will use the device for 8 weeks. The research also explores whether the devices effects differ between male and female Veterans and whether it benefits those with other conditions like obstructive sleep apnea or those taking medications such as prazosin. Participants will be evaluated before and after the 8-week period using the Pittsburgh Sleep Quality Index to measure changes in subjective sleep quality. Additional assessments include various physiological sleep measures, cardiovascular function tests, and autonomic nervous system evaluations. The study will monitor safety and adherence throughout, aiming to better understand NightWares effects on sleep and cardiovascular health in this population. Total participation duration includes the 8 weeks of device use plus assessments.

NightWare and Cardiovascular Health in Veterans With PTSD