[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100279862":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":48,"centralContacts":52,"locations":57,"responsibleParty":74,"collaborators":76,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":31,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":31,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":31,"overallStatus":59,"whyStopped":31,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"John D. Dingell VA Medical Center","FED",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Acute episodic hypoxia","EXPERIMENTAL","To test development of ventilatory augmentation following episodic hypoxia, defined as increased Hypoxic Ventilatory Response (HVR) from early to late hypoxic exposure episodes.",[13,14],"Procedure: Acute episodic hypoxia","Procedure: Sham",{"label":16,"type":10,"description":17,"interventionNames":18},"Supplemental oxygen","To use supplemental oxygen to decrease peripheral chemoreceptor activity in patients with SCI and central SDB. In addition, perform a repeat evaluation after treatment with supplemental oxygen or sham O2 for 6 weeks to determine if correction of chronic intermittent hypoxia, which mitigates sensory LTF, results in decreased propensity to central apnea.",[19,14],"Procedure: Supplemental oxygen",{"label":21,"type":10,"description":22,"interventionNames":23},"Trazodone or placebo","examine the effect of trazodone on breathing during sleep",[24,25],"Drug: Trazodone","Drug: Placebo",[27,32,35,40,44],{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","The subjects will undergo 30 minutes of baseline monitoring followed by 15 episodes of one minute of episodic hypoxia with supplemental CO2 to maintain isocapnia. This is followed by a 45 minute recovery period.",[9],null,{"type":28,"name":16,"description":33,"armGroupLabels":34,"otherNames":31},"Supplemental oxygen therapy for 6 weeks",[16],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"DRUG","Trazodone","100mg before bedtime",[21],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":31},"Placebo","One placebo pill before-bedtime",[21],{"type":28,"name":45,"description":46,"armGroupLabels":47,"otherNames":31},"Sham","Room air will be administered instead of episodic hypoxia or supplemental oxygen..",[9,16],[49],{"name":50,"affiliation":5,"role":51},"M Safwan Badr, M.D.","PRINCIPAL_INVESTIGATOR",[53],{"name":50,"role":54,"phone":55,"phoneExt":31,"email":56},"CONTACT","313-576-3548","m.badr@va.gov",[58],{"facility":5,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Detroit","Michigan","48201","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-83.04575,42.33143,{"lat":69,"lon":68},[72],{"name":73,"role":54,"phone":55,"phoneExt":31,"email":31},"M. Safwan Badr, MD",{"type":75,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[77],{"name":78,"class":6},"United States Department of Defense","100279862","phase-4-treatment-of-sleep-apnea-in-patients-with-cervical-spinal-cord-injury-100279862",false,"NCT02922894","Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury","Inclusion Criteria:\n\n1. healthy adults between the ages of 18 - 89\n2. chronic spinal cord injury patients (T6 and above), \\> 3 months since injury and not on mechanical ventilation, and have not received mechanical ventilation via tracheostomy in the past.\n\nExclusion Criteria:\n\n1. subjects ≤ 17 yrs old\n2. Pregnant and lactating females\n3. History of head trauma that resulted in neurological symptoms or loss of consciousness\n4. advanced heart, lung, metabolic, liver or chronic kidney disease.\n5. severe obstructive or restrictive respiratory defect by PFTs or history of tracheostomy\n6. extreme obesity defined for this protocol as BMI ≥ 40 kg\u002Fm2 (to avoid the effect of morbid obesity on ventilation).",true,"ALL","18 Years","89 Years",{"count":90,"type":91},100,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (\\>6 months post-injury).",[97,98],"Sleep Apnea","Spinal Cord Injury","2026-06-29",{"date":101,"type":102},"2026-07-01","ACTUAL",{"date":104,"type":102},"2017-06-09",{"date":106,"type":91},"2027-01-30",{"name":5,"class":6},1]