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Could a pacifier help babies with down syndrome breathe better at night?

NCT ID NCT07658053

Prevention 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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a special pacifier, called CURAPROX, can reduce the severity of obstructive sleep apnea (OSA) in infants with Down syndrome. Fifty infants will be enrolled at one month old, with half using the pacifier and half not. At six months, sleep tests will measure breathing problems to see if the pacifier helps.

What this could mean

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

Active substance
CURAPROX biofunctional pacifier
What this could lead to
If it works, this could point toward a simple, low-cost way to prevent or reduce sleep apnea in infants with Down syndrome, potentially improving their development.
What could go wrong
This is a small, early-stage study with only 50 infants, so results may not apply to everyone. The pacifier may not reduce sleep apnea, and long-term benefits are unknown.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 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

23 to 38 days

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: * Group 1 (infants with CURAPROX pacifier) * Age 1 month (±1 week) * Children diagnosed with free and homogeneous trisomy 21 * For whom a consultation is planned at \~1 month in the department of genetics * Affiliated to a social security scheme * With informed consent of the 2 legal representatives * Group 2 (infants without CURAPROX pacifier) * Infants included in the OMF21 study (sponsored by HCL, n°ID-RCB 2025-A01900-49, approved by ethical committee Nord-Ouest IV on October 9th 2025) * With informed consent of the 2 legal representatives for re-use of the data Exclusion Criteria: * Group 1 (infants with CURAPROX pacifier) * Diagnosed with mosaic trisomy 21 * Born preterm (gestation age at birth \<37 weeks) * Known allergy to silicone * Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies * Group 2 (infants without CURAPROX pacifier) - Use of the CURAPROX pacifier for ≥1 month

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Conditions

The condition(s) this trial relates to.

Down syndrome sleep apnea syndrome obstructive sleep apnea syndrome prevention target

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

  • Hôpital Femme-Mère-Enfant, Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant

    Bron, 69500, France

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