Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrom
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) i
| Condition(s) | Obstructive Sleep Apnea, Down Syndrome (Trisomy 21) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 by Fauroux et al. (2024), 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. However, polysomnography (PSG - the gold standard method for diagnosing OSA) is poorly accessible, highlighting |
| Who can participate | 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. |
| Ages | 5 Months to 6 Months |
| Sex | All |
| Lead sponsor | Hospices Civils de Lyon |
| Locations | Bron, France |
| Start date | 2026-04-01 |
| NCT ID | NCT07195253 |
| Official listing | https://clinicaltrials.gov/study/NCT07195253 |