NightWare and Cardiovascular Health in Women With PTSD

Starting soon · Not applicable · Has a placebo group

Conditions studied: Post Traumatic Stress Disorder, Cardiovascular Diseases, Autonomic Dysfunction, Vascular Stiffness, Nightmare, Endothelial Dysfunction, Kidney Diseases, Renal Dysfunction, Trauma and Stressor Related Disorders

In brief

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.

Key facts

Study ID

NCT07021014

Run by

University of Colorado, Denver

People needed

36

Starts

2025-07-01

Expected to finish

2028-07-01

Last updated by the study team

2025-06-13

Who can join

Age: 22 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy
• Nocturia that causes awakening from sleep
• Epworth Sleepiness Scale: 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
• Known sleep walking or acting out dreams (contraindication to NightWare use)
• Diagnosis or suspicion of dementia
• Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)
• Current use of vitamin/supplements (including melatonin) or anti-inflammatory medications, participants will be included if they are willing to stop taking vitamin/supplements or anti-inflammatory medications 2 weeks prior to the first vascular visit.
• Current or planned participation in an interventional study during the present study
• Participants must have access to wireless internet and two power outlets where they sleep

Where it is running

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• University of Colorado CCTSI CTRC — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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