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NCT07238465 · ClinicalTrials.gov registry record · Phase 3
Exploring Sympathetic Nervous System Function in Individuals With Down Syndrome
A Phase 3 study, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT07238465: Recruiting Phase 3 study, sponsored by University of Colorado, Denver.
NCT07238465 is a Phase 3 study that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07238465, a Phase 3 study, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- OTHER Caffeine
- OTHER Fear Response
- OTHER Cold Stress
- OTHER Pain Response
- OTHER 12-Hour Fast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2026-04-06 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
What NCT07238465 shows while recruiting
NCT07238465 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 5 interventions - of which Caffeine is the first listed.
NCT07238465 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07238465 about?
NCT07238465 is a clinical study titled "Exploring Sympathetic Nervous System Function in Individuals With Down Syndrome". 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 maint...
What is the current status of trial NCT07238465?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2026-04-06. Estimated completion is 2029-12.
What interventions are being tested in trial NCT07238465?
The interventions under investigation include: Caffeine (OTHER), Fear Response (OTHER), Cold Stress (OTHER), Pain Response (OTHER), 12-Hour Fast (OTHER).
Who is sponsoring clinical trial NCT07238465?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07238465's enrollment target sits among peer trials
200 1353rd of 2000 higher than 613 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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