NightWare and Cardiovascular Health in Veterans With PTSD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-88
SponsorVA Office of Research and Development

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

Qualifiers

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);

Disqualifiers

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

Trial design

Treatments tested in this trial

  • NightWare

Treatment groups

125 Participants
are divided into 2 treatment groups