Trial Summary
What is the purpose of 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 is for veterans with PTSD who frequently experience nightmares. Participants should be interested in testing a wrist-wearable device called NightWare, aimed at improving sleep and potentially cardiovascular health.Inclusion Criteria
I often have nightmares that disturb my sleep.
Resting blood pressure (BP) below 160/100 mmHg
Willingness not to use any other application which collects heart rate data on the phone and watch used for NightWare
+6 more
Exclusion Criteria
I do not have any uncontrolled health conditions like high blood pressure or active heart disease.
Shift workers
I have a seizure disorder.
+11 more
Participant Groups
The study tests the effectiveness of NightWare, a prescription device worn on the wrist during sleep. It's designed to help veterans with PTSD by reducing nightmares and possibly enhancing cardiovascular health.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NightWare activeExperimental Treatment1 Intervention
Intervention with NightWare Therapeutic System
Group II: NightWare ShamPlacebo Group1 Intervention
NightWare app disabled; device will not deliver an intervention
NightWare is already approved in United States for the following indications:
🇺🇸 Approved in United States as NightWare for:
- Post-traumatic stress disorder (PTSD) related nightmares
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rocky Mountain Regional VA Medical Center, Aurora, COAurora, CO
Loading ...
Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor