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

Not yet recruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

October 31, 2027

Study Completion Date

October 31, 2027

Conditions
Obstructive Sleep ApneaDown Syndrome (Trisomy 21)
Interventions
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) 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."

BEHAVIORAL

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).

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 of all children in our sleep unit."

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.

OTHER

Neurocognitive evaluation

The Brunet-Lézine test will be administered by a neuropsychologist. Global score will be calculated along with its four subscores (posture, hand-eye coordination, language, sociability).

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.

Trial Locations (1)

69500

Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant, Bron

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT07195253 - Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome | Biotech Hunter | Biotech Hunter