Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome

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Conditions studied: Obstructive Sleep Apnea, Down Syndrome (Trisomy 21)

In brief

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)).

Key facts

Study ID

NCT07658053

Run by

Hospices Civils de Lyon

People needed

50

Starts

2026-07-01

Expected to finish

2029-01-01

Last updated by the study team

2026-06-18

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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