NCT07238465 · University of Colorado, Denver
Exploring Sympathetic Nervous System Function in Individuals With Down Syndrome
(DIVE)
What this study is about
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.
View original scientific description
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. This 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.
Interventions
OTHER
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. The 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.
OTHER
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. The 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.
OTHER
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. The 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.
OTHER
Caffeine
Caffeine acts as a stimulant to the sympathetic nervous system leading to an increase in blood pressure, heart rate, and release of catecholamines. The 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.
OTHER
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. The 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.
OTHER
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.
Primary outcome measures
Seated Baseline Concentration of Plasma Catecholamines
Time frame: Seated baseline blood draw, prior to stressors
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Concentration of Plasma Catecholamines During Cold Pressor Test
Time frame: During the cold stress test, around or up to 5 minutes
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Baseline Standing Concentration of Plasma Catecholamines
Time frame: Standing baseline blood draws, prior to fear simulation
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
First Fear Simulation, Concentration of Plasma Catecholamines
Time frame: During the first virtual reality fear stressor, around 5 minutes
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Second Fear Simulation, Concentration of Plasma Catecholamines
Time frame: During the second fear simulation, around 15 minutes into the test
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
First Minute of Pain Patch, Concentration of Plasma Catecholamines
Time frame: Blood draw will take place within 1-minute of the application of the pain patch.
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
15 Minutes into Pain Patch Application, Concentration of Plasma Catecholamines
Time frame: Blood draw will occur about 15 minutes after the application of the pain patch.
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
12-Hour Fast, Concentration of Plasma Catecholamines
Time frame: Blood draw will occur following a 12-hour fast inducing hypoglycemia
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Seated Baseline Blood Draw, Concentration of Plasma Catecholamines
Time frame: Blood draw will occur prior to ingestion of caffeine pill
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
30 Minutes Following Ingestion of Caffeine Pill(s), Concentration of Plasma Catecholamines
Time frame: Blood draw will occur around 30 minutes following participant ingestion of caffeine pill(s)
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
60 Minutes Following Ingestion of Caffeine Pill(s), Concentration of Plasma Catecholamines
Time frame: Blood draw will occur around 60 minutes following participant ingestion of caffeine pill(s)
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Baseline Standing Concentration of Plasma Catecholamines Prior to Maximal Exercise Test
Time frame: Standing baseline blood draw, prior to maximal exercise test
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Standing Concentration of Plasma Catecholamines at End of Maximal Exercise Test
Time frame: This blood draw will occur at the very end or immediately following the maximal exercise test on the treadmill
Investigators will use metabolomic techniques to quantify plasma concentrations of epinephrine, norepinephrine, and dopamine in all participants before, during (in some stressors), and after the six stressor tests. These metabolites will provide insight into sympathetic nervous system activation in individuals with Down syndrome compared to those without Down syndrome.
Seated Baseline Heart Rate, Prior to Cold Pressor Test
Time frame: Resting seated baseline, prior to cold pressor test, up to or around 5 minutes
Investigators will collect beat-to-beat heart rate recordings in all participants before, during (in some stressors), and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate Collected During Cold Pressor Test
Time frame: Collected throughout the Cold Pressor Test, around 6 minutes in total
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Standing Baseline Heart Rate, Prior to Fear Simulations
Time frame: Standing baseline, prior to fear simulations, up to or around 5 minutes
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, First Fear Simulation
Time frame: Continuous heart rate will be collected during the first fear simulation, which will last around or up to 10 minutes
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, First Calming Simulation
Time frame: Continuous heart rate will be recorded during the first calming simulation, which will follow the first fear simulation and will last up to or around 10 minutes.
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, Second Fear Simulation
Time frame: Continuous heart rate will be recorded during the second fear simulation, which will follow the first calming simulation and will last up to or around 10 minutes.
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, Second Calming Simulation
Time frame: Continuous heart rate will be recorded during the second calming simulation, which will follow the second fear simulation and will last up to or around 10 minutes.
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, Baseline Prior to Pain Patch
Time frame: Baseline seated heart rate recordings will occur prior to application of pain patch, up to or around 5 minutes
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, During Pain Patch
Time frame: Continuous heart rate will be recorded following the application of the capsaicin pain patch, up to or around 15 minutes
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, Baseline 12-Hour Fast
Time frame: Resting baseline will be recorded prior (and on a separate day from) the 12-hour fast, up to or around 5 minutes.
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, 12-Hour Fast
Time frame: Seated heart rate recordings will occur following a 12-hour fast, up to or around 15 minutes.
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, Seated Baseline, Caffeine Consumption
Time frame: Resting baseline heart rate will be recording prior to caffeine consumption, up to or around 5 minutes
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, Following Caffeine Consumption
Time frame: Continuous heart rate recordings will occur immediately following caffeine consumption, up to or around 60 minutes.
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, Baseline Prior to Maximal Exercise Test
Time frame: Baseline heart rate recordings will occur prior to the maximal exercise test, up to or around 5 minutes.
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Heart Rate, Maximal Exercise Test
Time frame: Continuous heart rate recordings will take place throughout the maximal aerobic exercise test on the treadmill, up to or around 20 minutes
Investigators will collect beat-to-beat heart rate recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Seated Baseline Blood Pressure, Prior to Cold Pressor Test
Time frame: Resting seated baseline, prior to cold pressor test, up to or around 5 minutes
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure Collected During Cold Pressor Test
Time frame: Collected throughout the Cold Pressor Test, around 6 minutes in total
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Standing Baseline Blood Pressure, Prior to Fear Simulations
Time frame: Standing baseline, prior to fear simulations, up to or around 5 minutes
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, First Fear Simulation
Time frame: Continuous blood pressure will be recorded during the first fear simulation, which will last up to or around 10 minutes.
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, First Calming Simulation
Time frame: Continuous blood pressure will be recorded during the first calming simulation, which will follow the first fear simulation and will last up to or around 10 minutes.
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, Second Fear Simulation
Time frame: Continuous blood pressure will be recorded during the second fear simulation, which will follow the first calming simulation and will last up to or around 10 minutes.
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, Second Calming Simulation
Time frame: Continuous blood pressure will be recorded during the second calming simulation, which will follow the second fear simulation and will last up to or around 10 minutes.
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, Baseline Prior to Pain Patch
Time frame: Baseline seated blood pressure recordings will occur prior to application of pain patch, up to or around 5 minutes
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, During Pain Patch
Time frame: Continuous blood pressure will be recorded following the application of the capsaicin pain patch, up to or around 15 minutes
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, Baseline 12-Hour Fast
Time frame: Resting baseline will be recorded prior (and on a separate day from) the 12-hour fast, up to or around 5 minutes.
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, 12-Hour Fast
Time frame: Seated blood pressure recordings will occur following a 12-hour fast, up to or around 15 minutes.
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, Seated Baseline, Caffeine Consumption
Time frame: Resting baseline blood pressure will be recording prior to caffeine consumption, up to or around 5 minutes
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, Following Caffeine Consumption
Time frame: Continuous blood pressure recordings will occur immediately following caffeine consumption, up to or around 60 minutes.
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, Baseline Prior to Maximal Exercise Test
Time frame: Baseline blood pressure recordings will occur prior to the maximal exercise test, up to or around 5 minutes.
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Blood Pressure, Maximal Exercise Test
Time frame: Continuous blood pressure recordings will take place throughout the maximal aerobic exercise test on the treadmill, up to or around 20 minutes
Investigators will collect beat-to-beat blood pressure recordings in all participants before, during, and after the six stressor tests. These cardiovascular perturbations will provide insight into sympathetic nervous system modulation in individuals with Down syndrome compared to those without Down syndrome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18-50 yrs old and apparently healthy individuals
- Ability to understand the study and give assent to participate
- Has a study partner who can attend all visits for the individuals with DS, and answer questionnaires, provide consent when necessary
- Corrected or non-existent congenital heart disease
- Euthyroid or on stable thyroid medication dose for at least 6 months
- Free from cardiovascular, pulmonary, inflammatory, or metabolic disease in the past 6 months that would prevent participation in study procedures
- BMI \<45kg/m2
- Ability to tolerate repeated blood draws / catheter placement
Exclusion criteria
- Hypertension (resting systolic blood pressure \[SBP\] ≥140 and/or diastolic blood pressure \[DBP\] ≥90 mmHg) this includes those on medications to treat hypertension
- Hypotension (resting BP of \<90/60 mmHg)
- Cancer in the last six months
- Any heart-rate-altering medications or any other medication that may modify metabolic responses
- Self-reported diabetes or use of glucose-lowering medication
- Tobacco products, including vaping, or marijuana use
- Currently pregnant
- Post-menopausal women Specific Exclusion Criteria for Certain Stressors:
- Orthopedic limitations that would prohibit exercise or movement for exercise
- Fracture of limb to be immersed for CPT
- Open cut or sore on hand to be immersed for CPT
- Raynaud's syndrome for CPT
- Chronic caffeine drinkers for caffeine stressor (consumption of caffeine in the last 7 days)
Where
- Aurora, Colorado
Collaborators
National Institute on Aging (NIA), Linda Crnic Institute for Down Syndrome, GLOBAL Down Syndrome Foundation, University of Colorado Colorado Clinical and Translational Sciences Institute
Related conditions & keywords
Frequently asked questions
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A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations