NightWare and Cardiovascular Health in Women With PTSD (NCT07021014) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
NightWare and Cardiovascular Health in Women With PTSD
United States36 participantsStarted 2025-07
Plain-language summary
The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.
Who can participate
Age range22 Years – 40 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy, as determined by medical history
* Group Specific Eligibility
* PTSD Group
* Lifetime PTSD: screened using Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and confirmed via Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
* Prior trauma exposure: screened using Brief Trauma Questionnaire (BTQ)
* Self-report having repetitive nightmares contributing to disrupted sleep
* Poor overall sleep quality: PSQI score 6 or higher
* Control Group
* No lifetime PTSD: screened using PC-PTSD-5
* No prior trauma exposure: screened using BTQ
* Do not self-report having repetitive nightmares contributing to disturbed sleep
Exclusion Criteria:
* Pre-existing (e.g., diabetes, liver, kidney disease) or unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer) or systemic illness that would interfere with interpretation of the study outcomes
* Body Mass Index ≥ 40 kg/m2
* Use of medications that might influence cardiovascular or renal function (i.e., antihypertensive, lipid lowering medications, GLP-1/GIP RAs)
* Active infection (note, anyone with an active infection would become eligible once the infection has ended)
* Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork. Abnormal kidney function defined as creatinine \>1.3mg/dL. Abnormal liver function tests within 1.5x ULN. UCH Clinical Lab ULN for AST and ALT are 39 and 52, respectively. Women with TSH levels outside of the normal range…
What they're measuring
1
Brachial artery flow-mediated dilation (FMD)
Timeframe: PTSD vs controls at baseline. In PTSD group only, change with NightWare vs Sham (measured before and after 8 weeks of NightWare or sham conditions).