[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641242":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":67,"centralContacts":71,"locations":81,"responsibleParty":97,"collaborators":12,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":12,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":127,"whyStopped":12,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Infants with Down Syndrome without CURAPROX pacifier","NO_INTERVENTION","Infants with Down Syndrome, included in the study OMF21 (age: 6 months), who did not use the CURAPROX pacifier",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Infants with Down Syndrome with the CURAPROX pacifier","EXPERIMENTAL","infants with Down Syndrome with the pacifier",[18,19,20,21,22,23,24,25,26],"Device: CURAPROX pacifier use","Other: Pacifier diary","Diagnostic Test: Polysomnography (PSG) to explore OSA","Other: Non-nutritive sucking recording","Other: Oro-myo-functional clinical evaluation","Behavioral: Neurocognitive evaluation","Other: Sleep Disturbance Scale for Children","Other: Sleep Hygien Scale for Children","Other: PedsQL-Infants",[28,33,37,42,46,50,55,59,63],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":12},"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.",[14],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":12},"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.",[14],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":12},"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.\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.",[14],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":12},"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.\n\nIt will be recorded on the day of inclusion (1 month old) and on the day of polysomnography (6 months old).",[14],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":12},"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).",[14],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":12},"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).",[14],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":12},"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 for polysomnography in the sleep unit.",[14],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":12},"Sleep Hygien Scale for Children","The Sleep Hygiene Scale for Children is a short questionnaire answered by parents about their child's sleep habits.\n\nTotal score and scores for each sleep disorder will be calculated, according to the classical procedures during hospitalization for polysomnography in the sleep unit.",[14],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":12},"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).",[14],[68],{"name":69,"affiliation":5,"role":70},"Patricia FRANCO, PU-PH","PRINCIPAL_INVESTIGATOR",[72,77],{"name":69,"role":73,"phone":74,"phoneExt":75,"email":76},"CONTACT","4 27 85 60 52","+33","patricia.franco@chu-lyon.fr",{"name":78,"role":73,"phone":79,"phoneExt":75,"email":80},"Aurore GUYON, PhD","4 27 85 52 47","aurore.guyon@chu-lyon.fr",[82],{"facility":83,"status":12,"city":84,"state":12,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Hôpital Femme-Mère-Enfant, Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant","Bron","69500","France","FR",{"type":89,"coordinates":90},"Point",[91,92],4.91303,45.73865,{"lat":92,"lon":91},[95,96],{"name":69,"role":73,"phone":74,"phoneExt":75,"email":76},{"name":69,"role":70,"phone":12,"phoneExt":12,"email":12},{"type":98,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100641242","effects-of-a-pacifier-on-obstructive-sleep-apnea-and-its-repercussions-in-infants-with-down-syndrome-100641242",false,"NCT07658053","Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome","Effects of a Pacifier on the Development of Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome","TET21","Inclusion Criteria:\n\n* Group 1 (infants with CURAPROX pacifier)\n\n  * Age 1 month (±1 week)\n  * Children diagnosed with free and homogeneous trisomy 21\n  * For whom a consultation is planned at \\~1 month in the department of genetics\n  * Affiliated to a social security scheme\n  * With informed consent of the 2 legal representatives\n* Group 2 (infants without CURAPROX pacifier)\n\n  * Infants included in the OMF21 study (sponsored by HCL, n°ID-RCB 2025-A01900-49, approved by ethical committee Nord-Ouest IV on October 9th 2025)\n  * With informed consent of the 2 legal representatives for re-use of the data\n\nExclusion Criteria:\n\n* Group 1 (infants with CURAPROX pacifier)\n\n  * Diagnosed with mosaic trisomy 21\n  * Born preterm (gestation age at birth \\\u003C37 weeks)\n  * Known allergy to silicone\n  * Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies\n* Group 2 (infants without CURAPROX pacifier) - Use of the CURAPROX pacifier for ≥1 month","ALL","23 Days","38 Days",{"count":111,"type":112},50,"ESTIMATED","INTERVENTIONAL",[115],"NA","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, 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.\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 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.\n\nThe 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)).",[118,119],"Obstructive Sleep Apnea","Down Syndrome (Trisomy 21)",[121,122,123,124,125,126],"Sleep apnea","Down syndrome","Oro-myo-functional development","Sleep","Non-nutritive sucking","Pacifier","NOT_YET_RECRUITING","2026-06-16",{"date":130,"type":131},"2026-06-18","ACTUAL",{"date":133,"type":112},"2026-07-01",{"date":135,"type":112},"2029-01-01",{"name":5,"class":6},1]