Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome
Key facts
- Who runs it
- Hospices Civils de Lyon
- Where
- Bron, FranceSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 1 Apr 2026
- Expected to end
- 1 Apr 2028
- Type of study
- Observational
- Treatments tested
- Polysomnography (PSG) to explore OSA
- Oro-myo-functional clinical evaluation
- Sleep Disturbance Scale for Children
- Non-nutritive sucking recording
- Neurocognitive evaluation
- PedsQL-Infants
- Sleep Hygiene Scale for Children
- Record updated
- 3 April 2026
Who can take part
- Age
- 5 months to 6 months
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- (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
Who cannot take part
- Diagnosed with mosaic Down syndrome
- Known allergy to silicone
- Born preterm (gestation age at birth <37 weeks)
- Treated for OSA with Continuous Positive Airway Pressure
- Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies
- Refusal from legal representatives
Where in France
- Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfantBron, FranceContact: Patricia PF FRANCO, MD/PHDTaking people
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Infants with Down Syndrome
6 month-old infants with Down Syndrome recorded by polysomnography
Treatment: Polysomnography (PSG) to explore OSA, Oro-myo-functional clinical evaluation, Sleep Disturbance Scale for Children, Non-nutritive sucking recording, Neurocognitive evaluation, PedsQL-Infants, and Sleep Hygiene Scale for Children
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Exploring the Relationships Between Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome
- Record updated
- 3 April 2026