[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611275":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":65,"centralContacts":66,"locations":75,"responsibleParty":98,"collaborators":100,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":65,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":78,"whyStopped":65,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Individuals with Down syndrome","EXPERIMENTAL","The investigators will be recruiting participants between the ages of 18-50 for the study investigating responses to six sympathetic stressors compared to age and sex matched individuals without Down syndrome.",[13,14,15,16,17,18],"Other: Fear Response","Other: Cold Stress","Other: Pain Response","Other: Caffeine","Other: 12-Hour Fast","Other: Maximal Dynamic Exercise",{"label":20,"type":10,"description":21,"interventionNames":22},"Individuals without Down syndrome","The investigators will be recruiting individuals without Down syndrome between the ages of 18-50 to serve as the comparisons for individuals with Down syndrome across the six sympathetic stressors.",[13,14,15,16,17,18],[24,31,38,44,51,58],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Fear Response","Fear triggers the sympathetic nervous system, known as the 'fight-or-flight' response, which prepares the body to respond to a perceived threat by increasing heart rate, blood pressure, and releasing catecholamines. These measurements will be taken to examine the cardiovascular physiology of how individuals with DS will respond during a scary simulation.\n\nThe investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during a fear simulation using virtual reality goggles in individuals with Down syndrome, who have proposed autonomic dysfunction. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.",[9,20],[29,30],"Physiological Fear Response","Virtual Reality Simulation",{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Cold Stress","Cold triggers the sympathetic nervous system, known as the 'fight-or-flight' response, which prepares the body to respond to a perceived threat by increasing heart rate, blood pressure, and releasing catecholamines. These measurements will be taken to examine how individuals with DS will respond during a cold stress test.\n\nThe investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during a cold stress test in individuals with Down syndrome, who have proposed autonomic dysfunction. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.",[9,20],[36,37],"Cold Pressor Test","Cold Water",{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Pain Response","Pain triggers the sympathetic nervous system, known as the 'fight-or-flight' response, which prepares the body to respond to the perceived threat (i.e., hurt) by increasing heart rate, blood pressure, and releasing catecholamines. These measurements will be taken to examine how individuals with DS will respond during application of a painful patch.\n\nThe investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during application of a pain patch in individuals with Down syndrome, who have proposed autonomic dysfunction. This pain patch is similar to what someone would buy at the drug store for sore muscles. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.",[9,20],[43],"Capsaicin Patch",{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Caffeine","Caffeine acts as a stimulant to the sympathetic nervous system leading to an increase in blood pressure, heart rate, and release of catecholamines.\n\nThe investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed following ingestion of a caffeine pill (similar to \\~2 cups of coffee) in individuals with Down syndrome, who have proposed autonomic dysfunction. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.",[9,20],[49,50],"Caffeine Pill","Coffee",{"type":6,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"12-Hour Fast","Fasting-induced hypoglycemia triggers a 'fight-or-flight' response as the body attempts to raise low blood glucose levels to bring them back to 'normal'. These measurements will be taken to examine how individuals with DS will respond following a 12-hour abstinence from food, inducing low blood sugar.\n\nThe investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed following a 12-hour fast in individuals with Down syndrome, who have proposed autonomic dysfunction. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.",[9,20],[56,57],"Low Blood Sugar","Hypoglycemia",{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Maximal Dynamic Exercise","The investigators are looking at how plasma catecholamines (i.e., Epinephrine, Norepinephrine, and Dopamine), blood pressure, and heart rate are expressed during a treadmill maximal exercise test in individuals with Down syndrome, who have proposed autonomic dysfunction. This study will compare responses among individuals with Down syndrome to a control group without Down syndrome.",[9,20],[63,64],"VO2peak","Treadmill Exercise",null,[67,72],{"name":68,"role":69,"phone":70,"phoneExt":65,"email":71},"Sara R Sherman, PhD","CONTACT","303-724-0598","sara.r.sherman@cuanschutz.edu",{"name":73,"role":69,"phone":65,"phoneExt":65,"email":74},"Constance Brecl","constance.brecl@cuanschutz.edu",[76],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Linda Crnic Institute for Down Syndrome, University of Colorado Anschutz Medical Campus","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-104.83192,39.72943,{"lat":88,"lon":87},[91,95],{"name":92,"role":69,"phone":93,"phoneExt":65,"email":94},"Joaquin M Espinosa, PhD","303-724-7389","joaquin.espinosa@cuanschutz.edu",{"name":96,"role":69,"phone":65,"phoneExt":65,"email":97},"Angela Rachubinski, PhD","angela.rachubinski@cuanschutz.edu",{"type":99,"investigatorFullName":65,"investigatorTitle":65,"investigatorAffiliation":65,"oldNameTitle":65,"oldOrganization":65},"SPONSOR",[101,104,107,109],{"name":102,"class":103},"National Institute on Aging (NIA)","NIH",{"name":105,"class":106},"Linda Crnic Institute for Down Syndrome","UNKNOWN",{"name":108,"class":106},"GLOBAL Down Syndrome Foundation",{"name":110,"class":106},"University of Colorado Colorado Clinical and Translational Sciences Institute","100611275","phase-3-exploring-sympathetic-nervous-system-function-in-individuals-with-down-syndrome-100611275",false,"NCT07238465","Exploring Sympathetic Nervous System Function in Individuals With Down Syndrome","Dysautonomia InVestigation in Individuals With Down SyndromE: DIVE Study","DIVE","Inclusion Criteria:\n\n* 18-50 yrs old and apparently healthy individuals\n* Ability to understand the study and give assent to participate\n* Has a study partner who can attend all visits for the individuals with DS, and answer questionnaires, provide consent when necessary\n* Corrected or non-existent congenital heart disease\n* Euthyroid or on stable thyroid medication dose for at least 6 months\n* Free from cardiovascular, pulmonary, inflammatory, or metabolic disease in the past 6 months that would prevent participation in study procedures\n* BMI \\\u003C45kg\u002Fm2\n* Ability to tolerate repeated blood draws \u002F catheter placement\n\nExclusion Criteria:\n\n* Hypertension (resting systolic blood pressure \\[SBP\\] ≥140 and\u002For diastolic blood pressure \\[DBP\\] ≥90 mmHg) this includes those on medications to treat hypertension\n* Hypotension (resting BP of \\\u003C90\u002F60 mmHg)\n* Cancer in the last six months\n* Any heart-rate-altering medications or any other medication that may modify metabolic responses\n* Self-reported diabetes or use of glucose-lowering medication\n* Tobacco products, including vaping, or marijuana use\n* Currently pregnant\n* Post-menopausal women\n\nSpecific Exclusion Criteria for Certain Stressors:\n\n* Orthopedic limitations that would prohibit exercise or movement for exercise\n* Fracture of limb to be immersed for CPT\n* Open cut or sore on hand to be immersed for CPT\n* Raynaud's syndrome for CPT\n* Chronic caffeine drinkers for caffeine stressor (consumption of caffeine in the last 7 days)",true,"ALL","18 Years","50 Years",{"count":124,"type":125},200,"ESTIMATED","INTERVENTIONAL",[128],"PHASE3","Down syndrome (DS), the most common genetic cause of intellectual disability, is associated with widespread organ dysfunction, including abnormalities in the autonomic nervous system (ANS). The ANS regulates critical functions such as heart rate (HR) and blood pressure (BP), both essential for maintaining homeostasis and supporting physical activity. Individuals with DS often exhibit blunted HR responses to exercise-typically \\~30 beats per minute below expected levels-suggesting reduced sympathetic nervous system (SNS) activity. The SNS governs rapid changes in HR and BP during stress by releasing catecholamines: epinephrine (from the adrenal medulla) and norepinephrine (from sympathetic nerve endings). Despite its importance, SNS function has not been comprehensively assessed among individuals with DS.\n\nThis study addresses a critical knowledge gap by evaluating SNS responses to physiological stressors in individuals with DS. The investigators will measure beat-to-beat HR and BP, along with plasma catecholamine levels, in response to sympathetic activation, comparing individuals with DS to age- and sex-matched controls. Understanding the mechanisms of SNS dysfunction in DS is vital, as it likely underlies reduced exercise capacity and contributes to broader clinical challenges. These insights may guide targeted interventions to improve cardiovascular function, physical capacity, and overall quality of life in this understudied population.",[131,132],"Down Syndrome","Autonomic Dysfunction",[32,134,135,136,137,138,45,52,139,140,141,142],"Pain Responses","Fear","Exercise","Blood Pressure","Heart Rate","Catecholamines","Epinephrine","Norepinephrine","Dopamine","2026-04-28",{"date":145,"type":146},"2026-05-04","ACTUAL",{"date":148,"type":146},"2026-04-06",{"date":150,"type":125},"2029-12",{"name":5,"class":6},1]