[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100371592":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":51,"responsibleParty":75,"collaborators":30,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":30,"enrollmentInfo":88,"targetDuration":30,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":53,"whyStopped":30,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"acetazolamide","ACTIVE_COMPARATOR","To determine the effect of dampening chemoreceptor sensitivity AND decreasing plant gain. The investigators hypothesize that combined therapy with PAP, acetazolamide and oxygen will be superior to PAP plus each intervention alone or placebo in reducing CAHI and the CO2 reserve during sleep in Veterans with CSA.",[13],"Drug: Acetazolamide + supplemental oxygen + PAP therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"zolpidem","To determine the effect of decreasing respiratory-related arousals on the propensity to develop central apnea. The investigators hypothesize that administration of PAP and zolpidem, will decrease respiratory-related arousals, CAHI and the CO2 reserve during sleep in Veterans with CSA compared to PAP plus placebo.",[18],"Drug: Zolpidem + PAP therapy",{"label":20,"type":10,"description":21,"interventionNames":22},"buspirone","To determine the effect of augmenting serotonin A1 receptor activity on breathing during sleep. The investigators hypothesize that administration of PAP and buspirone, a serotonin A1 receptor agonist; will reduce the propensity to central apnea during sleep in Veterans with CSA compared to PAP plus placebo.",[23],"Drug: Buspirone + PAP therapy",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Acetazolamide + supplemental oxygen + PAP therapy","Every participant will undergo measurement of the apneic threshold. The apneic threshold (AT) can be determined by inducing central apnea using non-invasive ventilation (NIV) or eliminating central apnea using supplemental CO2. The requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative. The central apnea index and the apneic threshold will be measured while participants receiving medication or oxygen (or both). In addition, participants will get PAP therapy during all the conditions.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Zolpidem + PAP therapy","The central apnea index and the apneic threshold will be compared under two conditions: zolpidem or placebo. In addition, participants will get PAP therapy during both the conditions.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Buspirone + PAP therapy","The central apnea index and the apneic threshold will be compared under two conditions: buspirone or placebo. In addition, participants will get PAP therapy during both the conditions.",[20],[40],{"name":41,"affiliation":42,"role":43},"M Safwan Badr, MD","John D. Dingell VA Medical Center, Detroit, MI","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"M S Badr, MD","CONTACT","(313) 576-1000","65710","sbadr@med.wayne.edu",[52],{"facility":42,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Detroit","Michigan","48201-1916","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-83.04575,42.33143,{"lat":63,"lon":62},[66,70,74],{"name":67,"role":47,"phone":68,"phoneExt":30,"email":69},"Edi Levi, MD","(313) 576-4451","edi.levi@va.gov",{"name":71,"role":47,"phone":72,"phoneExt":30,"email":73},"Erin Olgren, PhD MS","(313) 576-4448","erin.olgren@va.gov",{"name":41,"role":43,"phone":30,"phoneExt":30,"email":30},{"type":76,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100371592","phase-4-central-sleep-apnea--physiologic-mechanisms-to-inform-treatment-100371592",false,"NCT04118387","Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment","Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment","CSA","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 in the experiments\n\nExclusion Criteria:\n\n* less than 18 years old\n* pregnant or breastfeeding female\n* have severe respiratory disease that require to be on oxygen\n* recent health event that may affect the ability to participate in the study,\n* Body Mass Index (BMI) is \\>40 kg\u002Fm2\n* significant insomnia\n* mental instability\n* recent health event that may affect sleep\n* if at any time the principal investigator (PI) identifies that a certain drug is not suitable, or are unable to use the device that is used to treat sleep apnea, will be not be allowed to participate in the study",true,"ALL","18 Years",{"count":89,"type":90},200,"ESTIMATED","INTERVENTIONAL",[93],"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.",[96,97],"Sleep Disordered Breathing","Able Bodied",[99,100,101,102,103,104,105,106,107,108,109],"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","2026-03-11",{"date":112,"type":113},"2026-03-13","ACTUAL",{"date":115,"type":113},"2021-01-07",{"date":117,"type":90},"2026-12-31",{"name":5,"class":6},1]