NightWare use for cardiovascular health in women with PTSD-related nightmares

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores the effect of NightWare, a smartwatch-based therapy that disrupts nightmares, on vascular and renal biomarkers in premenopausal women with PTSD-related nightmares. It compares NightWare to a sham NightWare control to see if sleep improvements translate to better endothelial function, arterial stiffness, and RAAS-related renal regulation. The trial includes both PTSD-affected participants and healthy controls to contextualize biomarker changes. Participants undergo screening for PTSD, trauma exposure, sleep quality, and other health criteria, and will be assessed for safety and biomarker outcomes. The study is led by the University of Colorado, Denver, in collaboration with the Ludeman Center for Women's Health Research, at CU Anschutz and CU CCTSI CTRC sites.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Emily Larson, PhD
• Email: emily.a2.larson@cuanschutz.edu
• Phone: 7205233224

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.