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Scientists probe why hearts of people with down syndrome react differently to stress

NCT ID NCT07238465

Knowledge-focused Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at how the autonomic nervous system—which controls heart rate and blood pressure—works in people with Down syndrome. Researchers will measure stress responses using virtual reality, cold water, pain patches, caffeine, and exercise in 200 participants. The goal is to understand why people with Down syndrome often have a blunted heart rate response during activity, which may affect their physical fitness and overall health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal why people with Down syndrome often have lower exercise capacity, pointing toward future therapies to improve heart health and quality of life.
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve health, and results may not lead to new therapies for years, if at all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Down syndrome Motor Activity primary dysautonomia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autonomic dysfunction Down syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Linda Crnic Institute for Down Syndrome, University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

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