Actively Recruiting

Age: 5Months - 6Months
All Genders
NCT07195253

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

Led by Hospices Civils de Lyon · Updated on 2026-04-03

30

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 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 explore the relationships between oro-myo-facial functions, more specifically non-nutritive sucking, and the severity of OSA in 6 months old infants with DS. The main hypothesis is that OSA severity (estimated by the obstructive apnea hypopnea index on PSG) will be negatively correlated to non-nutritive sucking performance. Data from this study could help developing easily accessible protocols for OSA screening based on simple sucking recording. Some interventions could also be tested to prevent OSA from the beginning of life, like an innovative pacifier recently developed by a French start-up to stimulate nose breathing and to promote correct positioning of the tongue.

CONDITIONS

Official Title

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

Who Can Participate

Age: 5Months - 6Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infant aged 6 months (±3 weeks)
  • Diagnosed with Trisomy 21 (Down Syndrome)
  • Affiliated to a social security scheme
  • Informed consent provided by both legal representatives
Not Eligible

You will not qualify if you...

  • Diagnosed with mosaic Down syndrome
  • Born preterm (gestation age less than 37 weeks)
  • Currently treated for OSA with Continuous Positive Airway Pressure (CPAP)
  • Known allergy to silicone
  • Participating in another interventional study with ongoing exclusion period
  • Refusal from legal representatives

AI-Screening

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Trial Site Locations

Total: 1 location

1

Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant

Bron, France, 69500

Actively Recruiting

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Research Team

P

Patricia PF FRACO, MD, PhD

CONTACT

A

Aurore GUYON, PHD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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