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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 is a Phase 3 study that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 200 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07238465
The ClinicalTrials.gov registry entry for NCT07238465 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Caffeine is the first listed.
NCT07238465 reports 0 study locations.
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.
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