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

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)).

Conditions

• Obstructive Sleep Apnea
• Down Syndrome (Trisomy 21)

Interventions

DEVICE

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.

OTHER

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.

DIAGNOSTIC_TEST

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.

OTHER

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).

OTHER

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).

BEHAVIORAL

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).

OTHER

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.

OTHER

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.

OTHER

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).

Sponsors & Collaborators

• Hospices Civils de Lyon

  lead OTHER

Principal Investigators

• Patricia FRANCO, PU-PH · Hospices Civils de Lyon

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

23 Days

Max Age

38 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2029-01-01

Completion

2029-01-01

Countries

• France

Study Locations