Orofacial function and sleep breathing in infants with Down syndrome
Official title: Exploring the Relationships Between Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome
Run by Hospices Civils de Lyon · NCT07195253 · Data updated 2026-11-12
This study will test whether measures of mouth and facial muscle function and a non‑nutritive sucking recording at six months can help detect sleep apnea in infants with Down syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Months to 6 Months |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | April 1, 2028 |
| Study ends | April 1, 2028 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT07195253 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants with confirmed full trisomy 21 who are approximately 6 months old (±3 weeks), born at term, covered by social security, and whose two legal representatives consent are ideal candidates.
✕Probably not a fit
Infants with mosaic Down syndrome, those born before 37 weeks, infants already treated with CPAP, those allergic to silicone, or families who refuse PSG or consent are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study enrolls infants with trisomy 21 around six months of age and combines overnight polysomnography with a clinical oro‑myofunctional exam, caregiver sleep questionnaires, non‑nutritive sucking recordings, and early neurocognitive testing. Investigators will describe associations between orofacial function and objective sleep‑disordered breathing measures. The goal is to identify practical markers that could support earlier screening or referral when full polysomnography is not readily available. The protocol does not introduce interventional treatments and is focused on characterizing patterns at this early age.
Why it matters
Potential benefit: If successful, the findings could enable earlier and less invasive screening for obstructive sleep apnea in infants with Down syndrome, allowing timely referral and treatment that may improve development.
How similar studies have gone: Prior work (e.g., Fauroux et al., 2024) shows very high OSA prevalence in infants with Down syndrome and benefits of early intervention, but using oro‑myofunctional markers and non‑nutritive sucking as screening tools is still relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
Bron, France Recruiting
Study contacts
- Study coordinator: Patricia PF FRACO, MD, PhD
- Email: patricia.franco@chu-lyon.fr
- Phone: +33 4 27 85 60 52
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.