NightWare and Cardiovascular Health in Women With PTSD (NCT07021014)
Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (21 items).
Location: University of Colorado Anschutz Medical Campus — Aurora, Colorado
Age range: 22 Years to 40 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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 (0.5-5.0 mLU/L) will be referred to their PCP and will be allowed study entry once their TSH levels are normalized \> 3 months
- Plasma glucose \>126 mg/dl under fasting conditions
- Use of insulin or sulfonylureas
- Pregnant, within 12 months postpartum or currently breast feeding
- Current history of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate.
- Report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the C-SSRS).
- Shift workers
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
- University of Colorado CCTSI CTRC — Denver, Colorado
📞 Contact the Study Coordinator
Phone: (720) 523-3224
Email: emily.a2.larson@cuanschutz.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Post Traumatic Stress Disorder
- Targeting the Default Mode Network: A TMS-fMRI Study — Palo Alto, California
- MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder — Los Angeles, California
- Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD — Tallahassee, Florida
- Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD — Toronto, Ontario
- Nitric Oxide (NO) and Endothelial Dysfunction in Women With PTSD — Minneapolis, Minnesota
Explore by condition: All Post Traumatic Stress Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.