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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-6
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

Qualifiers

Aged 6 months (±3 weeks)

Diagnosed with Trisomy 21

Affiliated to a social security scheme

With informed consent of the 2 legal representatives

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators