Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age23-38
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, 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. Therefore, there is a need to develop new strategies to prevent 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 evaluate the effects of a pacifier used by infants with Down Syndrome (from the age of 1 months) on the severity of OSA at the age of 6 months, by comparing a group of infants with the pacifier vs a group of infants without the pacifier.

The main hypothesis is that infants who used the pacifier from 1 month- to 6 month-old will have lower OSA severity (estimated by the obstructive apnea hypopnea index on polysomnography (PSG)).

Eligibility criteria

Qualifiers

Group 1 (infants with CURAPROX pacifier)

Age 1 month (±1 week)

Children diagnosed with free and homogeneous trisomy 21

For whom a consultation is planned at ~1 month in the department of genetics

Disqualifiers

Group 1 (infants with CURAPROX pacifier)

Diagnosed with mosaic trisomy 21

Born preterm (gestation age at birth <37 weeks)

Known allergy to silicone

Trial design

Treatments tested in this trial

  • CURAPROX pacifier use
  • Pacifier diary
  • Polysomnography (PSG) to explore OSA
  • Non-nutritive sucking recording
  • Oro-myo-functional clinical evaluation
  • Neurocognitive evaluation
  • Sleep Disturbance Scale for Children
  • Sleep Hygien Scale for Children
  • PedsQL-Infants

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators