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Baby's suck may reveal sleep apnea risk in down syndrome

NCT ID NCT07195253

Knowledge-focused Sponsor: Hospices Civils de Lyon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30 six-month-old infants with Down syndrome to see if their sucking patterns are linked to the severity of obstructive sleep apnea (OSA). Researchers will measure sucking bursts and compare them to sleep study results. The goal is to find a simple way to screen for OSA early, potentially using a special pacifier.

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 could lead to simple, non-invasive screening tools for sleep apnea in infants with Down syndrome, using sucking patterns.
What could go wrong
This is a small observational study (30 infants) that only looks for relationships, not treatments. Results may not apply to all infants or lead to a proven screening method.

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.

Participants

About 30 people

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

Started

Apr 2026

Expected to finish

Apr 2028

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.

Who is studied

This study involves 6-month-old infants diagnosed with Down syndrome.

Ages

5 to 6 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: (infants with Down Syndrome) * Aged 6 months (±3 weeks) * Diagnosed with Trisomy 21 * Affiliated to a social security scheme * With informed consent of the 2 legal representatives Exclusion Criteria: * Diagnosed with mosaic Down syndrome * Born preterm (gestation age at birth \<37 weeks) * Treated for OSA with Continuous Positive Airway Pressure * Known allergy to silicone * Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies * Refusal from legal representatives.

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Conditions

The condition(s) this trial relates to.

Down syndrome obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

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

Down syndrome (trisomy 21) Obstructive sleep apnea

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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant

    RECRUITING

    Bron, 69500, France

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