[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609134":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":42,"responsibleParty":65,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":103,"whyStopped":25,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Trazodone","ACTIVE_COMPARATOR","To determine the effect of dampening respiratory arousals. The investigators hypothesize that PAP therapy with trazodone at 100 mg will be superior to CPAP alone in widening the CO2 reserve during sleep, decreasing respiratory arousals, and increasing the arousal threshold.",[13],"Drug: Trazodone + PAP therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Oxygen","To determine the effect of dampening peripheral chemoreceptor sensitivity. The investigators hypothesize that supplemental oxygen will be superior to CPAP alone in widening the CO2 reserve during sleep. The secondary analysis will use CAI as supplemental oxygen, which may obscure the detection of hypopneas based on desaturation.",[18],"Drug: Oxygen + PAP therapy",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Trazodone + PAP therapy","The central apnea index and the apneic threshold will be compared under two conditions: trazodone or placebo. In addition, participants will get PAP therapy during both the conditions.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Oxygen + PAP therapy","The central apnea index and the apneic threshold will be compared under two conditions: oxygen or room air. In addition, participants will get PAP therapy during both the conditions.",[15],[31],{"name":32,"affiliation":33,"role":34},"M Safwan Badr, MD","John D. Dingell VA Medical Center, Detroit, MI","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"M S Badr, MD","CONTACT","(313) 576-1000","65710","sbadr@med.wayne.edu",[43],{"facility":33,"status":25,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Detroit","Michigan","48201-1916","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-83.04575,42.33143,{"lat":53,"lon":52},[56,60,64],{"name":57,"role":38,"phone":58,"phoneExt":25,"email":59},"Susmita Chowdhuri, MD MS","(313) 576-4451","Susmita.Chowdhuri@va.gov",{"name":61,"role":38,"phone":62,"phoneExt":25,"email":63},"Lynn M Huber","(313) 576-3106","lynn.huber@va.gov",{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":66,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100609134","phase-4-central-apnea-in-heart-failure-physiological-mechanisms-to-inform-treatment-100609134",false,"NCT07210606","Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment","CSA-HF","Inclusion Criteria:\n\n* Men and Women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)\\>15\u002Fhour with CAHI\\>5\u002Fhour, will be included with the experiments.\n* Those with chronic, stable heart failure with reduced ejection fraction, receiving stable optimized guideline-based therapy and no hospitalizations or change in the medical regimen for the past 90 days before enrollment.\n\nExclusion Criteria:\n\n* less than 18 years old\n* pregnant or breastfeeding females\n* moderate or severe obstructive or restrictive lung disease, including supplemental o2 use\n* current treatment for CSA, including any form of PAP in the past three months, or phrenic nerve situation.\n* too ill to engage in the study procedures, inability to provide consent for participation.\n* a history of cardiac arrhythmia\n* Alcohol or substance abuse (less than 90 days sobriety) or current participation in a treatment program\n* depression or a history of suicidality\n* severe insomnia (ISI\\>21) or reported short sleep duration (\\\u003C6 hours)\n* PAP-emergent central sleep apnea\n* Lack of PAP acceptance\u002Fadherence after a one-week home PAP trial after enrollment.\n\nAdditional Trazodone Exclusions:\n\n* Prolonged QT on baseline ECG, using medications that inhibit CYP3A4\n* Patients with severe renal impairment (GFR \\\u003C 20ml\u002Fmin\u002F1.73m2) or end-stage renal disease",true,"ALL","18 Years",{"count":78,"type":79},200,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","Central sleep apnea (CSA) is common in patients with heart failure and those using opioid analgesics. Unfortunately, effective treatment of central apnea remains elusive, pressure therapy given the modest efficiency of positive airway pressure therapy. The focus of this proposal is to identify mechanistic pathways to guide future therapeutic interventions for central sleep apnea based on the strong premise that multi-modality therapy will normalize respiration and hence mitigate adverse long-term consequences of CSA. The investigators' proposed studies will test combination therapies, including positive airway pressure (PAP) plus a pharmacological agent who have heart failure or are using opioid analgesics. The investigators anticipate that findings will inform future clinical trials to improve care and quality of life among Veterans suffering from central sleep apnea, which remains difficult to treat using existing approaches.",[85,86],"Sleep Disordered Breathing","Able Bodied",[88,89,90,91,92,93,94,95,96,97,98,99,100,101,102],"Central Sleep Apnea","Polysomnography (PSG)","Respiratory Arousal Threshold","Apnea Hypopnea Index","Central Apnea Hypopnea Index","Breathing Instability","Apneic Threshold (AT)","Peripheral Chemoreflex Sensitivity","CO2 reserve","Plant gain","Controller gain","Cheyne Stokes Breathing (CSB)","Carotid Body Function","Peripheral Chemoresponsiveness","Heart Failure","NOT_YET_RECRUITING","2026-01-06",{"date":106,"type":107},"2026-01-07","ACTUAL",{"date":109,"type":79},"2026-10-01",{"date":111,"type":79},"2030-12-31",{"name":5,"class":6},1]