[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"trisomy-21\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:trisomy-21":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,57,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100479797","self-supporting-nasopharyngeal-airway-ssnpa-treating-upper-airway-obstruction-in-hypotonia-100479797",false,"NCT05527652","Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia","Inclusion Criteria:\n\n* Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA (apnea-hypopnea index \\[AHI\\]\\>10 or AHI\\>5 with nocturnal hypoxemia defined as oxygen saturation by pulse oximetry \\[SpO2\\] nadir \\\u003C=75%).\n* All subjects require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive\u002Finattentive behaviors)\n* Post adenotonsillectomy or those with contraindications to tonsillectomy.\n* Tonsil size 2+ or smaller.\n* Parent\u002Fcaregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.\n\nExclusion Criteria:\n\n* AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI\\\u003C5 with hypoxemia.\n* Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable\n* Active Coronavirus (COVID) 19 infections\n* End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values \\>60 mmHg for \\>10% of sleep time on PSG\n* Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit\u002FHyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded.\n* Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)\n* Moderate\u002Fsevere tracheobronchomalacia\n* Need for anticoagulative therapy\n* Bleeding disorder\n* Restrictive thoracic disorders","ALL","3 Years","21 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).",[26,27,28,29,30,31],"Obstructive Sleep Apnea","Hypertonia, Muscle","Nasal Airway Obstruction","Tolerance","Trisomy 21","Down Syndrome",[33,34,27,35,36,37,38,39,40,41,42,43],"Sleep Apnea Syndromes","Sleep Apnea, Obstructive","Apnea","Respiration Disorders","Respiratory Tract Diseases","Sleep Disorders, Intrinsic","Dyssomnias","Sleep Wake Disorders","Nervous System Diseases","Neuromuscular Manifestations","Neurologic Manifestations","RECRUITING","2026-03-10",{"date":47,"type":48},"2026-03-12","ACTUAL",{"date":50,"type":48},"2022-11-16",{"date":52,"type":20},"2026-12",{"name":54,"class":55},"University of Michigan","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":15,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":56},"100275349","the-human-trisome-project-100275349","NCT02864108","The Human Trisome Project","Research to Develop the Human Trisome Project Biobank","HTP","Inclusion Criteria:\n\nAnyone 6 months to 89 years old who:\n\n1. has Down syndrome (any type)\n2. does not have Down syndrome\n\nExclusion Criteria:\n\n1. Prisoners\n2. Wards of the state",true,"6 Months","89 Years",{"count":69,"type":20},2500,"OBSERVATIONAL","The Human Trisome Project will significantly increase the speed of Down syndrome research and the understanding of associated medical conditions. Its biobank will provide de-identified samples to research.",[31,30],"2025-10-22",{"date":75,"type":48},"2025-10-24",{"date":77,"type":4},"2016-07",{"date":79,"type":20},"2036-07",{"name":81,"class":55},"University of Colorado, Denver",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":56},"100513860","periodontitis-and-inflammation-in-children-with-down-syndrometrisomy-21-study-on-biological-samples-100513860","NCT05970965","Periodontitis and Inflammation in Children With Down Syndrome\u002FTrisomy 21: Study on Biological Samples","Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome\u002FTrisomy 21","NT21","Inclusion Criteria:\n\nCommon to all groups:\n\n* Age: 3 to 12\n* Patient affiliated to a social security program, beneficiary not covered by the AME.\n* Legal representatives who speak and understand French well enough to be able to read and understand the study information.\n* Legal representatives giving written consent for their child's participation in the study.\n\nSpecific:\n\nCase Group:\n\n* Trisomy 21 patient with gingival inflammation (subgroup 1)\n* Trisomy 21 patient with healthy gingiva on intact periodontium with no history of periodontitis (subgroup 2)\n\nControl Group: child meeting one of these criteria:\n\n* Patient with psychomotor retardation with no known repercussions on the orofacial sphere or immunity, presenting gingival inflammation (subgroup 1)\n* Patients with psychomotor retardation and no known repercussions on orofacial health or immunity, presenting gingival health on intact periodontium with no history of gingival inflammation (subgroup 2).\n* Patients with no known general pathology and gingival inflammation (subgroup 3)\n* Patients with no known general pathology and healthy gingiva on intact periodontium with no history of gingival inflammation (subgroup 4)\n\nExclusion Criteria:\n\nCommon to all groups:\n\n* Patient having received antibiotic prophylaxis, antibiotic therapy or anti-inflammatory treatment in the 3 months prior to inclusion\n* Patient included in another interventional research protocol or in a period of exclusion.\n* Patient on AME\n* Patients with a contraindication to the use of MEOPA:\n\n  * Patients requiring pure oxygen ventilation\n  * Intracranial hypertension\n  * Unevaluated head trauma\n  * New-onset, unexplained neurological abnormalities\n  * Pneumothorax\n  * Emphysema bubbles\n  * Gas embolism\n  * Diving accident\n  * Abdominal gas distension, occlusion\n  * Patient recently treated with ophthalmic gas (SF6, C3F8, C2F6)\n  * Known, unsubstituted vitamin B12 deficiency\n\nSpecific to Trisomy 21 group:\n\n\\- Patient with no genetic diagnosis","12 Years",{"count":92,"type":20},18,[23],"Since 2018, the Chicago Classification of Periodontal Diseases and Conditions, has listed Down syndrome (DS)\u002Ftrisomy 21 (T21) as a systemic disease with periodontal implications. Numerous studies report an increased prevalence and severity of periodontitis in DS\u002FT21 individuals under the age of 35. Approximately 35% of adolescents with DS show early signs of alveolar bone loss. However, very few studies have examined the role of immune deficiency in DS\u002FT21 patients in the pathogenesis of periodontitis. Indeed, periodontitis induced by bacterial plaque is virtually non-existent in the paediatric population, leaving the field to systemically-induced periodontitis.\n\nThe investigators hypothesize that specific neutrophil phenotypes in DS\u002FT21 patients are key to explaining the rapid progression to periodontitis.\n\nInvestigator's primary objective is to characterize the different oral and blood neutrophil subtypes in DS\u002FT21 children with gingival inflammation.\n\nInvestigator's secondary objective is to assess the involvement of different neutrophil subtypes in early periodontitis in children with DS\u002FT21.",[96,30],"Periodontitis",[98,30,99,100,101,102,103],"Down syndrome","psychomotor retardation","gingivitis","periodontitis","neutrophils","biological collection","2025-05-02",{"date":106,"type":48},"2025-05-06",{"date":108,"type":48},"2025-04-30",{"date":110,"type":20},"2027-04-30",{"name":112,"class":55},"Assistance Publique - Hôpitaux de Paris"]