[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475650":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":35,"locations":42,"responsibleParty":61,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":23,"eligibilityCriteria":71,"healthyVolunteers":68,"sex":72,"minAge":73,"maxAge":23,"enrollmentInfo":74,"targetDuration":23,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":45,"whyStopped":23,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Early-CPAP therapy group","EXPERIMENTAL","Individuals diagnosed with moderate-to-severe sleep-related breathing disorders (SRBDs) who will start CPAP therapy within the first 6 weeks after SCI.",[13],"Device: Continuous positive airway pressure (CPAP) therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Delayed-CPAP therapy group","ACTIVE_COMPARATOR","Individuals diagnosed with moderate-to-severe SRBDs who will start on CPAP therapy at the 5th month after SCI.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Non-CPAP therapy group","NO_INTERVENTION","Individuals who are diagnosed with no or mild SRBD.",null,[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DEVICE","Continuous positive airway pressure (CPAP) therapy","Continuous positive airway pressure (CPAP) therapy for moderate-to-severe sleep-related breathing disorders.",[15,9],[31],{"name":32,"affiliation":33,"role":34},"Julio C Furlan, MD, FRCPC","KITE Research Institute, University Health Network","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Lamisa Etu, BSc","CONTACT","4165973422","6285","LamisaFaria.Etu@uhn.ca",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"KITE Toronto Research Institute","RECRUITING","Toronto","Ontario","M4G 3V9","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.39864,43.70643,{"lat":55,"lon":54},[58],{"name":59,"role":38,"phone":39,"phoneExt":40,"email":60},"Mitsue Aibe","Mitsue.Aibe@uhn.ca",{"type":62,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[64],{"name":65,"class":6},"Sunnybrook Health Sciences Centre","100475650","outcomes-post-treatment-impact-on-motor-impairment-of-sleep-efficiency-in-sci-optimise-sci-trial-100475650",false,"NCT05473689","Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI (OPTIMISE SCI Trial)","Inclusion Criteria:\n\n* English-speaking adults (18 years of age or older)\n* Acute (≤ 30 days after injury), cervical\u002Fthoracic (injury level at C2 to T12), complete or incomplete (AIS A to D) SCI\n* Not being treated for sleep apnea prior to the spinal cord impairment onset.\n\nExclusion Criteria:\n\n* Non-traumatic spinal cord disease at risk for neurologic progression (e.g., demyelinating spine diseases such as neuromyelitis optica and multiple sclerosis, spinal cord malignancy)\n* Concomitant diseases of the central nervous system\n* Preinjury chronic pain\n* Other pre-existing diseases of the central nervous system\n* Significant psychiatric disorders with recent episode of exacerbation\n* Neuromuscular diseases\n* Current substance misuse\n* Known history of primary hypersomnia or secondary hypersomnia of any cause except for SRBDs (e.g., hypothyroidism, moderate or severe iron deficiency anemia, infections, depression, kidney failure, chronic fatigue syndrome, neurodegenerative diseases, and myotonic dystrophy)\n* Epilepsy\n* Vitamin B12 deficiency","ALL","18 Years",{"count":75,"type":76},66,"ESTIMATED","INTERVENTIONAL",[79],"NA","This randomized clinical trial will compare three groups of individuals with cervical\u002Fthoracic, complete or incomplete spinal cord injury (SCI) that will undergo: (i) early CPAP therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among adults at 6 weeks after SCI; (ii) delayed CPAP therapy in the management of moderate-to-severe SRBDs among adults at 22 weeks after SCI; and (iii) no treatment as they either have mild or no SRBD.",[82,83],"Spinal Cord Injuries","Spine Disease",[85,86],"sleep apnea","sleep-related breathing disorders","2024-12-05",{"date":89,"type":90},"2024-12-11","ACTUAL",{"date":92,"type":90},"2022-08-15",{"date":94,"type":76},"2025-07-31",{"name":5,"class":6},1]