[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607953":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":10,"centralContacts":51,"locations":61,"responsibleParty":78,"collaborators":10,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":10,"studyType":94,"phases":10,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infants with Down Syndrome",null,"6 month-old infants with Down Syndrome recorded by polysomnography",[13,14,15,16,17,18,19],"Diagnostic Test: Polysomnography (PSG) to explore OSA","Other: Oro-myo-functional clinical evaluation","Other: Sleep Disturbance Scale for Children","Other: Non-nutritive sucking recording","Behavioral: Neurocognitive evaluation","Other: PedsQL-Infants","Other: Sleep Hygiene Scale for Children",[21,26,30,34,38,43,47],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"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.\n\nOSA diagnosis will be made based on the obstructive apnea-hypopnea index (OAHI) resulting from the PSG. OSA will be diagnosed when OAHI ≥1.5\u002Fhour.",[9],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"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).",[9],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Sleep Disturbance Scale for Children","The Sleep Disturbance Scale for Children is a short questionnaire answered by parents about their child's sleep disorders.\n\nTotal score and scores for each sleep disorder will be calculated, according to the classical procedures during hospitalization of all children in our sleep unit.",[9],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"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.",[9],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"BEHAVIORAL","Neurocognitive evaluation","The Bayley Scales of Infant and Toddler Development (4th edition) will be administered by a neuropsychologist. Five subset scores (cognitive, receptive communication, expressive communication, fine motor, gross motor) will be calculated, along with three composite scores (cognitive, language, motor).",[9],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":10},"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.",[9],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"Sleep Hygiene Scale for Children","The Sleep Hygiene Scale for Children is a short questionnaire answered by parents about behavioral sleep disorders.\n\nTotal result (\"sleep hygiene issue\" : yes\u002Fno) and three scores (attachment parenting, translational coping, screen exposure) will be calculated, according to the classical procedures during hospitalization of all young children in our sleep unit.",[9],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":10,"email":56},"Patricia PF FRACO, MD, PhD","CONTACT","+33 4 27 85 60 52","patricia.franco@chu-lyon.fr",{"name":58,"role":54,"phone":59,"phoneExt":10,"email":60},"Aurore GUYON, PHD","+33 4 27 85 52 47","aurore.guyon@chu-lyon.fr",[62],{"facility":63,"status":64,"city":65,"state":10,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant","RECRUITING","Bron","69500","France","FR",{"type":70,"coordinates":71},"Point",[72,73],4.91303,45.73865,{"lat":73,"lon":72},[76],{"name":77,"role":54,"phone":55,"phoneExt":10,"email":56},"Patricia PF FRANCO, MD\u002FPHD",{"type":79,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100607953","oro-myofunctional-characteristics-and-obstructive-sleep-apnea-in-infants-with-down-syndrome-100607953",false,"NCT07195253","Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome","Exploring the Relationships Between Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome","OMF21","Inclusion Criteria:\n\n(infants with Down Syndrome)\n\n* Aged 6 months (±3 weeks)\n* Diagnosed with Trisomy 21\n* Affiliated to a social security scheme\n* With informed consent of the 2 legal representatives\n\nExclusion Criteria:\n\n* Diagnosed with mosaic Down syndrome\n* Born preterm (gestation age at birth \\\u003C37 weeks)\n* Treated for OSA with Continuous Positive Airway Pressure\n* Known allergy to silicone\n* Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies\n* Refusal from legal representatives.","ALL","5 Months","6 Months",{"count":92,"type":93},30,"ESTIMATED","OBSERVATIONAL","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.\n\nDown 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.\n\nOSA 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.\n\nThe 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.\n\nThe main hypothesis is that OSA severity (estimated by the obstructive apnea hypopnea index on PSG) will be negatively correlated to non-nutritive sucking performance.\n\nData 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.",[97,98],"Obstructive Sleep Apnea","Down Syndrome (Trisomy 21)",[100,101,102,103,104],"sleep apnea","Down Syndrome","oro-myofunctional development","sleep","non-nutritive sucking","2026-04-02",{"date":107,"type":108},"2026-04-03","ACTUAL",{"date":110,"type":108},"2026-04-01",{"date":112,"type":93},"2028-04-01",{"name":5,"class":6},1]