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Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome

Recruitingn/aAges 5 Months - 6 MonthsAllHospices Civils de Lyon
NCT07195253 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 the need to develop new strategies to prevent and to screen OSA early in infancy. OSA can be linke

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📋 Eligibility rules (as published)
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.
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What it tests

  • Polysomnography (PSG) to explore OSA
  • Oro-myo-functional clinical evaluation
  • Sleep Disturbance Scale for Children
  • Non-nutritive sucking recording
  • Neurocognitive evaluation
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Where

1 site
Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
Bron, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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