[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562940":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":24,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study)","EXPERIMENTAL","The aim of this pilot study is to examine whether clinically important indices during sleep are comparable between oxygen delivery by portable and by continuous flow.",[13],"Device: Portable oxygen concentrator Inogen G5 model",{"label":15,"type":10,"description":16,"interventionNames":17},"Reducing the frequency of obstructive apnea (Main study)","The arm of the main study is still under development",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Portable oxygen concentrator Inogen G5 model","The concentrator weighs 4.7 lbs. and has a battery life of 13 hours. It has 6 settings with 1 providing the lowest pulse flow and 6 provides the highest flow. The setting will be increased every 30 minutes by 1 when oxygen nadir is lower than 94% and or obstructive index is ≥ 5 \u002Fhour.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Raouf Amin, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Suzie Hicks, BS","CONTACT","513-636-4944","suzie.hicks@cchmc.org",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Cincinnati Children's Hospital Medical Center","RECRUITING","Cincinnati","Ohio","45229","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-84.51439,39.12711,{"lat":48,"lon":47},[51,53,55],{"name":31,"role":32,"phone":52,"phoneExt":24,"email":34},"5136364944",{"name":27,"role":32,"phone":24,"phoneExt":24,"email":54},"rauof.amin@cchmc.org",{"name":56,"role":57,"phone":24,"phoneExt":24,"email":24},"Narong Simakajornboon, PhD","SUB_INVESTIGATOR",{"type":59,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[61],{"name":62,"class":63},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100562940","comparison-of-a-demand-oxygen-delivery-100562940",false,"NCT06609694","Comparison of a Demand Oxygen Delivery","Comparison of a Demand Oxygen Delivery to Continuous Flow for Administration of Oxygen During Sleep","DOSA","Inclusion Criteria:\n\n1. Age 5-17 years with or without Down Syndrome (DS).\n2. Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40 \u002F hour: The rationale for selecting this range of OAHI is that a large number of children with DS with this range of OSA severity are untreated for months to years. It is important to understand the response to oxygen across the spectrum of disease severity. Notably, children with severe disease are left with few options (e.g., tracheostomy).\n3. Absence of clinically significant hypoxia defined as oxygen saturation \\\u003C 88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.\n\nExclusion Criteria:\n\n1. Current CPAP use with documented compliance (\\> 4 hrs\u002F night; \\> 70% of nights).\n2. Oxygen saturation \\\u003C 90% at rest during wakefulness\n3. Chronic daytime or nighttime use of supplemental oxygen.\n4. Unable to participate in a Polysomnogram (PSG).\n5. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.",true,"ALL","5 Years","17 Years",{"count":77,"type":78},10,"ESTIMATED","INTERVENTIONAL",[81],"NA","Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea.\n\nThe aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.",[84],"Obstructive Apnea",[86,87,88],"Sleep Apnea","Down Syndrome","Continuous Positive Airway Pressure (CPAP)","2026-01-05",{"date":91,"type":92},"2026-01-07","ACTUAL",{"date":94,"type":92},"2023-01-09",{"date":96,"type":78},"2028-12-01",{"name":5,"class":6},1]