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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06419959
Other study ID # CARB-005-23F
Secondary ID CX002762-01A124-
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2024
Est. completion date September 30, 2026

Study information

Verified date May 2024
Source VA Office of Research and Development
Contact Kerrie L Moreau, PhD
Phone (720) 885-1950
Email Kerrie.Moreau@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Device:
NightWare
Nightware 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.

Locations

Country Name City State
United States Rocky Mountain Regional VA Medical Center, Aurora, CO Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Pittsburgh Sleep Quality Index Sleep questionnaire with a scale of 0 to 21 with a higher score indicating a significant sleep disturbance Measured before and after 8 weeks of NightWare and sham conditions
Secondary Change in physiological sleep - total sleep time Total sleep duration (minutes) calculated through ambulatory electroencephalography. Measured before and after 8 weeks of NightWare and sham conditions
Secondary Change in endothelial function Brachial artery flow mediated dilation (FMD) using ultrasound Measured before and after 8 weeks of NightWare and sham conditions
Secondary 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. Measured before and after 8 weeks of NightWare and sham conditions
Secondary Change in large elastic artery stiffness Carotid-femoral pulse wave velocity (PWV) Measured before and after 8 weeks of NightWare and sham conditions
Secondary Change in large elastic artery stiffness Augmentation index and aortic blood pressure via pulse wave analysis Measured before and after 8 weeks of NightWare and sham conditions
Secondary Change in autonomic function - heart rate variability (HRV) Heart rate variability Measured before and after 8 weeks of NightWare and sham conditions
Secondary Change in physiological sleep - wake after sleep onset Wake after sleep (minutes) calculated through ambulatory electroencephalography. Measured before and after 8 weeks of NightWare and sham conditions
Secondary Change in physiological sleep - sleep efficiency Sleep efficiency (percentage) calculated through ambulatory electroencephalography. Measured before and after 8 weeks of NightWare and sham conditions
Secondary Change in physiological sleep - REM sleep REM sleep (minutes) calculated through ambulatory electroencephalography. Measured before and after 8 weeks of NightWare and sham conditions
Secondary Change in physiological sleep - Deep sleep Deep sleep (minutes) calculated through ambulatory electroencephalography. Measured before and after 8 weeks of NightWare and sham conditions
Secondary Change in physiological sleep - Light sleep Light sleep (minutes) calculated through ambulatory electroencephalography. Measured before and after 8 weeks of NightWare and sham conditions
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