Clinical trial NCT07021014: NightWare and Cardiovascular Health in Women With PTSD
Official title: Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Cardiovascular Diseases
Autonomic Dysfunction
Vascular Stiffness
Nightmare
Endothelial Dysfunction
Kidney Diseases
Renal Dysfunction
Trauma and Stressor Related Disorders
Keywords: Sleep
Trauma and Stressor Related Disorders
Post Traumatic Stress Disorder
Cardiovascular Diseases
Kidney Diseases
Renal Dysfunction
Autonomic Dysfunction
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Ludeman Family Center for Women's Health Research
First posted: 2025-06-13
Enrollment: 36
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Observational study (women with PTSD-related nightmares vs control group without PTSD-related nightmares); In women with PTSD-related nightmares only: randomized, double-blind, placebo (i.e., sham intervention) controlled parallel pilot study
Primary purpose: TREATMENT

Brief 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.

Detailed description: Women are disproportionally affected by posttraumatic stress disorder (PTSD), a debilitating mental health disorder that profoundly increases cardiovascular disease (CVD) risk. Biological processes including vascular dysfunction (i.e., impaired endothelial function, arterial stiffening), increased renin-angiotensin-aldosterone system (RAAS) activity, and altered renal vascular control and function may contribute to the pathophysiological link between PTSD and CVD. Sleep is a key regulator of cellular and tissue repair, free radical detoxification, oxidative stress, inflammation, autonomic and endocrine balance and crucial for cardiovascular health. Sleep disturbances due to nightmares are a hallmark symptom of PTSD that cause significant distress and may independently contribute to elevated CVD risk in individuals with PTSD. As such, interventions aimed at treating trauma-related nightmares are a promising therapeutic approach in ameliorating the cardiovascular consequences of PTSD.

NightWare™, a smart-watch based application that uses biometric data and vibrotactile feedback to disrupt nightmares, is an FDA approved digital therapeutic system for the treatment of nightmares in adults (≥22 years) with PTSD. While a preliminary study demonstrated that 30 days of NightWare treatment improved subjective sleep quality in Veterans, the influence of NightWare treatment on vascular and renal function in young women with PTSD-related nightmares is unknown. These investigations are critical among women who, despite having 2x greater prevalence of PTSD compared to men, and a differential progression of PTSD, CVD, and chronic kidney disease (CKD), are underrepresented in the literature.

Accordingly, the investigators will examine if the NightWare digital therapeutic system improves vascular and renal function in premenopausal women with PTSD-related nightmares, and whether these improvements restore them to levels observed in age-matched women without PTSD. We will employ 1) cross-sectional comparisons between two groups of women: those with PTSD and nightmares (PTSD group) and those without PTSD and nightmares (age-matched control group); and 2) a short-term (8-week) NightWare or sham intervention in women with nightmares related to PTSD.

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

Primary outcomes:
measure: 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).
Secondary outcomes:
measure: Large artery elastic stiffness
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).
Other outcomes:
measure: Large artery elastic stiffness-carotid artery
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).
measure: Autonomic function-baroreflex sensitivity
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).
measure: Autonomic function- heart rate variability
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).
measure: Blood pressure
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).
measure: Estimated glomerular filtration rate (eGFR)
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).
measure: Renal vascular control
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).
measure: Renal functional reserve
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).
measure: Pittsburgh Sleep Quality Index (PSQI)
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).
measure: Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
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).
measure: PTSD Checklist for DSM-5 (PCL-5)
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).
measure: Nightmare Disorder Index (NDI)
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).
measure: Columbia Suicide Severity Rating Scale (CSSR-S)
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).
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Denver
country: United States
facility: University of Colorado CCTSI CTRC
state: Colorado
Study officials:
References: