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| Name | Class |
|---|---|
| Ludeman Family Center for Women's Health Research | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental NightWare | Experimental | 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. |
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| Sham NightWare | Sham Comparator | In women with PTSD-related nightmares randomized to the sham condition, the NightWare intervention will not be enabled |
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| Control Women without PTSD-related Nightmares | No Intervention | Age-matched women without PTSD-related nightmares will complete baseline testing only (no intervention). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NightWare | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brachial artery flow-mediated dilation (FMD) | FMD of the brachial artery, calculated as a percentage, is an index of vascular function. A higher number is a general indicator of better vascular function. | 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 | Description | Time Frame |
|---|---|---|
| Large artery elastic stiffness | Carotid-femoral pulse wave velocity (PWV). A higher number is a general indicator of worse vascular function. | 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 | Description | Time Frame |
|---|---|---|
| Large artery elastic stiffness-carotid artery | Carotid artery compliance using carotid artery ultrasound; a higher carotid artery compliance is a general indicator of better vascular function. | 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). |
Inclusion Criteria:
Exclusion Criteria:
cisgender premenopausal women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Larson, PhD | Contact | 7205233224 | emily.a2.larson@cuanschutz.edu | |
| Kerrie Moreau, PhD | Contact | kerrie.moreau@cuanschutz.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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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
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| Sham NightWare | Device | NightWare decive will not deliver an intervention (i.e., no vibration) |
|
| Autonomic function-baroreflex sensitivity |
Cardiovagal baroreflex sensitivity (cBRS) measured using beat-to-beat time series of systolic blood pressures (finger photo-plethysmography) and R-R interval (three-lead electrocardiogram) will be recorded simultaneously at 1,000 Hz. |
| 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). |
| Autonomic function- heart rate variability | Heart rate variability | 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). |
| Blood pressure | Seated blood pressure measured in mmHg | 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). |
| Estimated glomerular filtration rate (eGFR) | Serum cystatin C, alongside demographic information, will be used to estimate kidney filtration of waste and excess water. A low eGFR can indicate renal dysfunction. | 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). |
| Renal vascular control | Peak change in renal vascular resistance in response to sympathoexcitation via cold pressor test | 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). |
| Renal functional reserve | Peak change in creatinine clearance (calculated using urine creatinine, serum creatinine, urine flow rate) following ingestion of oral protein | 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). |
| Pittsburgh Sleep Quality Index (PSQI) | Sleep questionnaire with a scale of 0 to 21 with a higher score indicating a significant sleep disturbance | 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). |
| Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A) | Sleep questionnaire to assess frequency of seven disruptive nocturnal behaviors; scores range from 0-21 with higher scores indicating more severe PTSD-related sleep disturbances. | 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). |
| PTSD Checklist for DSM-5 (PCL-5) | Presence and severity of PTSD symptoms questionnaire; scores range from 0-80 with higher scores indicating more severe PTSD symptoms. | 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). |
| Nightmare Disorder Index (NDI) | 5-item questionnaire related to nightmares; scores range from 0-20 with higher score indicates more severe nightmare symptoms. | 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). |
| Columbia Suicide Severity Rating Scale (CSSR-S) | Questionnaire used for suicide risk assessment; categorizes level of suicide risk (low, moderate, high) based on responses to questions about suicidal ideation and behavior. | 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). |
| University of Colorado CCTSI CTRC | Denver | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D002318 | Cardiovascular Diseases |
| D054969 | Primary Dysautonomias |
| D007674 | Kidney Diseases |
| D051437 | Renal Insufficiency |
| D000068099 | Trauma and Stressor Related Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D001523 | Mental Disorders |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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