NightWare and Cardiovascular Health in Women With PTSD

NCT ID: NCT07021014

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2028-07-31

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.

Conditions

Post Traumatic Stress Disorder; Cardiovascular Diseases; Autonomic Dysfunction; Vascular Stiffness; Nightmare; Endothelial Dysfunction; Kidney Diseases; Renal Dysfunction; Trauma and Stressor Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental NightWare

In women with PTSD-related nightmares randomized to the active condition, when the stress index is reached during sleep, NightWare will intervene with varying degrees of vibratory stimulation to the watch over a variable length of time to arouse the person out of the nightmare without awakening.

Group Type: EXPERIMENTAL

NightWare

Intervention Type: DEVICE

A wearable digital therapeutic platform consisting of an Apple Watch and iPhone pre-provisioned with Nightware intervention app that will deliver a mild vibration to the watch after detecting individual having a nightmare based on Nightware proprietary algorithm, arousing the individual and disrupting nightmare without awakening.

Sham NightWare

In women with PTSD-related nightmares randomized to the sham condition, the NightWare intervention will not be enabled

Group Type: SHAM_COMPARATOR

Sham NightWare

Intervention Type: DEVICE

NightWare decive will not deliver an intervention (i.e., no vibration)

Control Women without PTSD-related Nightmares

Age-matched women without PTSD-related nightmares will complete baseline testing only (no intervention).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NightWare

A wearable digital therapeutic platform consisting of an Apple Watch and iPhone pre-provisioned with Nightware intervention app that will deliver a mild vibration to the watch after detecting individual having a nightmare based on Nightware proprietary algorithm, arousing the individual and disrupting nightmare without awakening.

Intervention Type: DEVICE

Sham NightWare

NightWare decive will not deliver an intervention (i.e., no vibration)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ludeman Family Center for Women's Health Research

UNKNOWN

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

University of Colorado CCTSI CTRC

Denver, Colorado, United States

Countries

United States

Central Contacts

Emily Larson, PhD

Role: CONTACT

emily.a2.larson@cuanschutz.edu

7205233224

Kerrie Moreau, PhD

Role: CONTACT

kerrie.moreau@cuanschutz.edu

Facility Contacts

Emily A Larson, PhD

Role: primary

emily.a2.larson@cuanschutz.edu

720-523-3224

Emily Larson, PhD

Role: primary

emily.a2.larson@cuanschutz.edu

720-523-3224

Other Identifiers

24-1948

Identifier Type: -

Identifier Source: org_study_id