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

This trial accepts healthy volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • NightWare

    Device

    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.

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: NightWare activeExperimental treatment 1 intervention
Group B: NightWare ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Pittsburgh Sleep Quality Index

Sleep questionnaire with a scale of 0 to 21 with a higher score indicating a significant sleep disturbance

Time frame
Measured before and after 8 weeks of NightWare and sham conditions

Secondary outcomes

1

Change in physiological sleep - total sleep time

Total sleep duration (minutes) calculated through ambulatory electroencephalography.

Time frame
Measured before and after 8 weeks of NightWare and sham conditions
2

Change in endothelial function

Brachial artery flow mediated dilation (FMD) using ultrasound

Time frame
Measured before and after 8 weeks of NightWare and sham conditions
3

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.

Time frame
Measured before and after 8 weeks of NightWare and sham conditions
4

Change in large elastic artery stiffness

Carotid-femoral pulse wave velocity (PWV)

Time frame
Measured before and after 8 weeks of NightWare and sham conditions

Other outcomes

Sponsors and contacts

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