Actively Recruiting
Dysautonomia InVestigation in Individuals With Down SyndromE: DIVE Study
Led by University of Colorado, Denver · Updated on 2026-05-04
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the function of the sympathetic nervous system (SNS) in individuals with Down syndrome (DS), a common genetic cause of intellectual disability often linked to widespread organ dysfunction. This study focuses on how the SNS regulates key processes like heart rate and blood pressure during stress. People with DS usually have lower heart rate responses to exercise, indicating possible reduced SNS activity. The study aims to fill a knowledge gap by comparing SNS responses between individuals with DS and matched controls to better understand mechanisms behind reduced exercise capacity and other health issues in DS. Participants will undergo tests involving six different stressors that activate the SNS: cold stress, fear using virtual reality, pain from a capsaicin patch, caffeine intake, a 12-hour fast, and maximal exercise on a treadmill. During these stressors, researchers will measure beat-to-beat heart rate and blood pressure, as well as plasma catecholamine levels (hormones involved in the stress response). Blood samples will be analyzed with metabolomics and proteomics to explore hormonal SNS dysfunction in DS. The study includes two groups: individuals with DS and age- and sex-matched individuals without DS. Participants will be involved in multiple visits where their heart rate, blood pressure, and hormone levels are continuously monitored during each stressor. Blood draws will occur before, during, and after these stress tests, and participants will also complete questionnaires assessing their pain and emotional responses. The research team will track these measurements closely to understand SNS activation patterns and their impact. The trial will run until December 2029, with participants aged 18 to 50 years and includes healthy volunteers.
CONDITIONS
Brief Title
Exploring Sympathetic Nervous System Function in Individuals With Down Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 50 years and apparently healthy
- Ability to understand the study and give assent to participate
- Has a study partner who can attend all visits for individuals with Down syndrome and provide consent when necessary
- Corrected or no 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
- Body mass index (BMI) under 45 kg/m2
- Ability to tolerate repeated blood draws or catheter placement
You will not qualify if you...
- Hypertension (resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg), including those on medication for hypertension
- Hypotension (resting blood pressure below 90/60 mmHg)
- Cancer within the last six months
- Use of heart-rate-altering medications or any medication that may affect metabolic responses
- Self-reported diabetes or use of glucose-lowering medication
- Use of tobacco products, including vaping, or marijuana
- Currently pregnant
- Post-menopausal women
- Orthopedic limitations preventing exercise or movement for exercise
- Fracture of limb to be immersed during cold pressor test
- Open cut or sore on hand to be immersed during cold pressor test
- Raynaud's syndrome for cold pressor test
- Chronic caffeine consumption (caffeine intake within last 7 days) for caffeine stressor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 days depending on scheduling
Participants undergo a series of six stress tests that mimic common daily stressors to evaluate sympathetic nervous system activation. These include cold stress, fear simulation using virtual reality, pain response via a pain patch, caffeine ingestion, a 12-hour fast, and a maximal treadmill exercise test. Heart rate, blood pressure, and plasma catecholamine levels will be measured during and around these stressors to assess cardiovascular and hormonal responses.
Up to 6 visits, each corresponding to one of the stressors
Trial Site Locations
Total: 1 location
1
Linda Crnic Institute for Down Syndrome, University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
S
Sara R Sherman, PhD
C
Constance Brecl
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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