NightWare and Cardiovascular Health in Women With PTSD

Launched by UNIVERSITY OF COLORADO, DENVER · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "NightWare and Cardiovascular Health in Women With PTSD," is looking to see if a special program called NightWare can help improve heart and kidney health in women who have PTSD-related nightmares. The study will focus on premenopausal women who experience these nightmares and struggle with poor sleep quality. Researchers want to find out if using NightWare can bring their health markers back to levels similar to those of women their age who do not have PTSD.

To participate in this study, women must be in good health and either have a history of PTSD with nightmares or be part of a control group without any PTSD or trauma history. Participants will be asked to complete various questionnaires to determine their eligibility. If accepted, they can expect to use NightWare, which is designed to help improve their sleep and ultimately their cardiovascular and kidney health. It's important to note that participants will need access to wireless internet and power outlets at home for the study. The trial is not yet recruiting, but it aims to provide valuable insights into the health of women dealing with PTSD.

Gender

FEMALE

Eligibility criteria

• 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 (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