Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome (NCT07658053) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome
France50 participantsStarted 2026-07-01
Plain-language summary
Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals. In children, OSA can have long-term consequences on the development and on the cardiovascular system.
Down Syndrome (DS) is a genetic disorder associated with intellectual disability and many comorbidities. The prevalence of OSA is particularly high in patients with DS, from infancy. In a recent study, OSA was diagnosed in 97% infants and early diagnosis and intervention from the age of 6 months was associated with better neurocognitive outcome at 3 years old. Therefore, there is a need to develop new strategies to prevent OSA early in infancy.
OSA can be linked to some orofacial abnormalities presented by patients with DS. Indeed, orofacial functions and structures ca play a crucial role in OSA. For example, nose breathing allows the tongue to act as a stimulator of the transverse maxillary growth during childhood, allowing the upper airway to develop properly.
The primary objective of the present study is to evaluate the effects of a pacifier used by infants with Down Syndrome (from the age of 1 months) on the severity of OSA at the age of 6 months, by comparing a group of infants with the pacifier vs a group of infants without the pacifier.
The main hypothesis is that infants who used the pacifier from 1 month- to 6 month-old will have lower OSA severity (estimated by the obstructive apnea hypopnea index on polysomnography (PSG)).
Who can participate
Age range
23 Days – 38 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial hasn't started recruiting yet, can you help me find out when it might open and whether it would be worth waiting for it before starting other treatments for my child's sleep apnea?
2This study is looking at whether a pacifier can reduce the obstructive apnea hypnopnea index in infants with Down syndrome — can you explain what that index measures and what a meaningful improvement would look like for my child specifically?
3Because this trial is listed as Phase NA, which often applies to non-drug interventions like a pacifier, what do you think is currently known or unknown about the safety of using a pacifier as a sleep apnea intervention in infants with Down syndrome?
4Are there standard treatments for obstructive sleep apnea in infants with Down syndrome that my child should be considered for now, rather than waiting to see if this trial opens?
5What would my child need to go through to participate in this kind of study — for example, would they need sleep studies or overnight monitoring — and how would that fit into our current care routine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.