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

Condition(s) studied

Investigational drug(s) / intervention(s)

CURAPROX pacifier use: The CURAPROX pacifier is a biofunctional pacifier developed to promote nasal breathing and a healthy oro-facial development, available for sale to the general public. It will be given to infants when they are 1 month old, until the last visit at 6 months.

Pacifier diary: A diary will be filled in by the caregivers for 2 consecutive days each month until the visit at the hospital (at 6 months). Parents will be reminded to fill in the dairy by a phone call.

Polysomnography (PSG) to explore OSA: Patients will undergo full-night PSG (including electrocardiogram to monitor heart rate and the JAWAC system to record mandibular movements) at the age of 6 months in the sleep unit of Hôpital Femme-Mère-Enfant (Bron, France) to explore OSA, included in the routine care of children with DS. OSA diagnosis will be made based on the obstructive apnea-hypopnea index (OAHI) resulting from the PSG. OSA will be diagnosed when OAHI ≥1.5/hour.

Non-nutritive sucking recording: Non-nutritive sucking performance will be recorded through an experimental method using a classical pacifier, equipped with pressure sensors. Recording will last about 10 minutes. Variables related to sucking performance (maximum amplitude, frequency of sucking bursts, etc.) will be recorded. It will be recorded on the day of inclusion (1 month old) and on the day of polysomnography (6 months old).

Oro-myo-functional clinical evaluation: Orofacial myofunctional evaluation will be conducted by a physiotherapist according to the OMES-E (Orofacial Myofunctional Evaluation with Scores for Nursing Infants) during the hospitalization for polysomnography (at 6 months old).

Neurocognitive evaluation: The Bayley Scale (4th edition) will be administered by a neuropsychologist. Global score will be calculated along with its four subscores (cognitive, language, motor).

Sleep Disturbance Scale for Children: The Sleep Disturbance Scale for Children is a short questionnaire answered by parents about their child's sleep disorders. Total score and scores for each sleep disorder will be calculated, according to the classical procedures during hospitalization for polysomnography in the sleep unit.

Sleep Hygien Scale for Children: The Sleep Hygiene Scale for Children is a short questionnaire answered by parents about their child's sleep habits. Total score and scores for each sleep disorder will be calculated, according to the classical procedures during hospitalization for polysomnography in the sleep unit.

PedsQL-Infants: The PedsQL-Infants questionnaire is designed to evaluate quality of life in infants. It will be given to parents during their child's hospitalization for polysomnography (at 6 months old).

Study summary

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

Primary outcome measure(s)

• Obstructive apnea hypnopnea index — Month 6
  OAHI (/h) will be measured by PSG. Night PSG will take place during a 24h-stay at the hospital when infants are 6 months old.

Trial sites (1)

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