NightWare and Cardiovascular Health in Veterans With PTSD (NCT06419959) | Clinical Trial Compass
RecruitingNot Applicable
NightWare and Cardiovascular Health in Veterans With PTSD
United States125 participantsStarted 2025-09-10
Plain-language 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.
Who can participate
Age range22 Years – 88 Years
SexALL
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Inclusion criteria
✓. 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);
✓. Fasted glucose \<126 mg/dL;
✓. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher;
✓. Epworth Sleepiness Scale (ESS): Question #8 score above "0" will prompt an additional question: Do you drive ("get behind the wheel") when you are drowsy? The answer must be "No" to be enrolled in the study due to safety concerns;
✓. Wireless Internet and two power outlets in sleeping location;
Exclusion criteria
✕. 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;
What they're measuring
1
Change in Pittsburgh Sleep Quality Index
Timeframe: Measured before and after 8 weeks of NightWare and sham conditions
✕. Current history (past 3 months) of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate;
✕. Participants will be excluded if they report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the Columbia-Suicide Severity Rating Scale \[C-SSRS\]).
✕. Shift workers (due to circadian rhythm disruption);