Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome
NCT ID: NCT07195253
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
30 participants
OBSERVATIONAL
2025-10-31
2027-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Infants with Down Syndrome
6 month-old infants with Down Syndrome recorded by polysomnography
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.
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).
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.
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.
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).
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.
Interventions
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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.
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).
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.
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.
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).
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.
Eligibility Criteria
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Inclusion Criteria
* Aged 6 months (±3 weeks)
* Diagnosed with Trisomy 21
* Affiliated to a social security scheme
* With informed consent of the 2 legal representatives
Exclusion Criteria
* Born preterm (gestation age at birth \<37 weeks)
* Treated for OSA with Continuous Positive Airway Pressure
* Known allergy to silicone
* Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies
* Refusal from legal representatives.
5 Months
6 Months
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
Bron, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69HCL25_0309
Identifier Type: -
Identifier Source: org_study_id
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