NightWare and Cardiovascular Health in Adults With PTSD (NCT05365607) | Clinical Trial Compass
CompletedNot Applicable
NightWare and Cardiovascular Health in Adults With PTSD
United States40 participantsStarted 2022-06-24
Plain-language summary
The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular aging and autonomic function in adults with nightmares related to PTSD.
Who can participate
Age range22 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/d;
✓. non-smokers;
✓. no use of vitamin supplements or anti-inflammatory medications, or willing to stop 1 month prior to the vascular visit;
✓. Pittsburgh Sleep Quality Index (PSQI) score 6 or higher;
Exclusion criteria
✕. uncontrolled hypertension;
✕. current or preexisting CVD or cancers (with the exception of past skin cancers) or active infection;
✕. diabetes;
✕. 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 large elastic artery stiffness -carotid artery
Timeframe: Measured before and after 6 weeks of NightWare and sham conditions
2
Change in endothelial function
Timeframe: Measured before and after 6 weeks of NightWare and sham conditions
3
Change in 1utonomic function - BRS
Timeframe: Measured before and after 6 weeks of NightWare and sham conditions
✕. current use (or within previous 6 months) of hormone therapy in postmenopausal women;
✕. current substance (including marijuana) or alcohol use disorder (past 12 months) per the SCID-5 (see methods of Research Strategy). Adults with past substance or alcohol use disorders will be allowed to participate.
✕. Prazosin use; however, participant may be included if tapered by prescribing provider. Taper must be completed and individual must be off prazosin for 2 days prior to enrollment;