[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594558":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":34,"locations":43,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":24,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":24,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":105,"overallStatus":107,"whyStopped":24,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: NightWare",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham NightWare","SHAM_COMPARATOR","In women with PTSD-related nightmares randomized to the sham condition, the NightWare intervention will not be enabled",[19],"Device: Sham NightWare",{"label":21,"type":22,"description":23,"interventionNames":24},"Control Women without PTSD-related Nightmares","NO_INTERVENTION","Age-matched women without PTSD-related nightmares will complete baseline testing only (no intervention).",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"DEVICE","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.",[9],{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":24},"NightWare decive will not deliver an intervention (i.e., no vibration)",[15],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Emily Larson, PhD","CONTACT","7205233224","emily.a2.larson@cuanschutz.edu",{"name":41,"role":37,"phone":24,"phoneExt":24,"email":42},"Kerrie Moreau, PhD","kerrie.moreau@cuanschutz.edu",[44,61],{"facility":45,"status":24,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-104.83192,39.72943,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":60,"phoneExt":24,"email":39},"Emily A Larson, PhD","720-523-3224",{"facility":62,"status":24,"city":63,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"University of Colorado CCTSI CTRC","Denver",{"type":52,"coordinates":65},[66,67],-104.9847,39.73915,{"lat":67,"lon":66},[70],{"name":36,"role":37,"phone":60,"phoneExt":24,"email":39},{"type":72,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[74],{"name":75,"class":76},"Ludeman Family Center for Women's Health Research","UNKNOWN","100594558","nightware-and-cardiovascular-health-in-women-with-ptsd-100594558",false,"NCT07021014","NightWare and Cardiovascular Health in Women With PTSD","Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare","Inclusion Criteria:\n\n* Healthy, as determined by medical history\n* Group Specific Eligibility\n* PTSD Group\n* 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)\n* Prior trauma exposure: screened using Brief Trauma Questionnaire (BTQ)\n* Self-report having repetitive nightmares contributing to disrupted sleep\n* Poor overall sleep quality: PSQI score 6 or higher\n* Control Group\n* No lifetime PTSD: screened using PC-PTSD-5\n* No prior trauma exposure: screened using BTQ\n* Do not self-report having repetitive nightmares contributing to disturbed sleep\n\nExclusion Criteria:\n\n* 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\n* Body Mass Index ≥ 40 kg\u002Fm2\n* Use of medications that might influence cardiovascular or renal function (i.e., antihypertensive, lipid lowering medications, GLP-1\u002FGIP RAs)\n* Active infection (note, anyone with an active infection would become eligible once the infection has ended)\n* Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork. Abnormal kidney function defined as creatinine \\>1.3mg\u002FdL. 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\u002FL) will be referred to their PCP and will be allowed study entry once their TSH levels are normalized \\> 3 months\n* Plasma glucose \\>126 mg\u002Fdl under fasting conditions\n* Use of insulin or sulfonylureas\n* Pregnant, within 12 months postpartum or currently breast feeding\n* 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.\n* Report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the C-SSRS).\n* Shift workers\n* Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy\n* Nocturia that causes awakening from sleep\n* 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\n* Known sleep walking or acting out dreams (contraindication to NightWare use)\n* Diagnosis or suspicion of dementia\n* Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)\n* Current use of vitamin\u002Fsupplements (including melatonin) or anti-inflammatory medications, participants will be included if they are willing to stop taking vitamin\u002Fsupplements or anti-inflammatory medications 2 weeks prior to the first vascular visit.\n* Current or planned participation in an interventional study during the present study\n* Participants must have access to wireless internet and two power outlets where they sleep",true,"FEMALE","22 Years","40 Years",{"count":89,"type":90},36,"ESTIMATED","INTERVENTIONAL",[93],"NA","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.",[96,97,98,99,100,101,102,103,104],"Post Traumatic Stress Disorder","Cardiovascular Diseases","Autonomic Dysfunction","Vascular Stiffness","Nightmare","Endothelial Dysfunction","Kidney Diseases","Renal Dysfunction","Trauma and Stressor Related Disorders",[106,104,96,97,102,103,98],"Sleep","NOT_YET_RECRUITING","2025-06-05",{"date":110,"type":111},"2025-06-13","ACTUAL",{"date":113,"type":90},"2025-07",{"date":115,"type":90},"2028-07",{"name":5,"class":6},2]