[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484569":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":45,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":43,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":43,"overallStatus":47,"whyStopped":43,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyperoxia","EXPERIMENTAL","Determine the effect of sustained hyperoxia overnight vs room air overnight on ventilatory control during sleep, including the apneic threshold, carbon-dioxide reserve and chemosensitivity measured via pressure support ventilation (PSV) during non-rapid eye movement sleep (NREM) sleep.",[13],"Other: Hyperoxia",{"label":15,"type":10,"description":16,"interventionNames":17},"Acetazolamide (ACZ)","Determine the effect of acetazolamide on cerebrovascular responsiveness to CO2 during wake and sleep. Participants will receive oral ACZ therapy for 6 days, While on the medication following studies will be performed - experimental night study, experimental day study, polysomnography night study (PSG).",[18],"Drug: Acetazolamide",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"OTHER","The ventilatory effects of brief hyperoxia will be assessed by analyzing control breaths on room air immediately preceding the hyperoxic exposure, and comparing with the primary end-point, nadir minute ventilation breath, immediately following the brief hyperoxic exposure.",[9],[25],"oxygen",{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Acetazolamide","Participants with sleep apnea will ingest capsules containing either placebo or acetazolamide 500 mg twice a day for 6 days. On the final 4 consecutive nights while still on ACZ, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG.",[15],[32],"ACZ",[34],{"name":35,"affiliation":36,"role":37},"Susmita Chowdhuri, MD MS","John D. Dingell VA Medical Center, Detroit, MI","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Ruchi Rastogi, MS","CONTACT","(313) 576-4464",null,"ruchi.rastogi@va.gov",[46],{"facility":36,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Detroit","Michigan","48201-1916","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-83.04575,42.33143,{"lat":57,"lon":56},[60,61],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":35,"role":37,"phone":43,"phoneExt":43,"email":43},{"type":63,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[65],{"name":66,"class":6},"John D. Dingell VA Medical Center","100484569","phase-1-sleep-disordered-breathing-with-opioid-use-100484569",false,"NCT05589753","Sleep Disordered Breathing With Opioid Use","Targeting Chemoreceptor Control of Breathing During Sleep to Mitigate Opioid-Associated Sleep Disordered Breathing","SDB","Inclusion Criteria:\n\n* Veterans, age 18-89 years\n* Veterans with prescription opioids\n\nExclusion Criteria:\n\n* Patients with BMI\\>40kg\u002Fm2 will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control\n* Patients with history of unresolved\u002Funtreated cardiac disease, including recent myocardial infarction, recent bypass surgery, untreated atrial and ventricular tachy-bradycardias\n* Congestive heart failure with Cheyne-Stokes respiration (CSR)\n* Current unstable angina\n* Recent stroke\n* Untreated schizophrenia\n* Untreated hypothyroidism\n* Unresolved seizure disorder\n* Severe respiratory, neurological, liver and renal diseases\n* Unstable psychiatric disorders\u002Funtreated PTSD\n* Traumatic brain injury\n* Pregnant women\n* Significant sleep disorder such as narcolepsy, parasomnias disorder\n* Failure to give informed consent\n* Patients on tramadol and suboxone\u002Fbuprenorphine",true,"ALL","18 Years","89 Years",{"count":80,"type":81},150,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","There is an increased risk for sleep disordered breathing (SDB), sleep-related hypoventilation and irregular breathing in individuals on chronic prescription opioid medications. Almost 30% of a veteran sleep clinic population had opioid-associated central sleep apnea (CSA). The proposal aims to identity whether oxygen and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in chronic opioid use via different mechanisms. We will study additional clinical parameters like quality of life, sleep and pain in patients with and without opioid use. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea with opioid use. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea.",[88,89,90],"Sleep Apnea","Opioid Use","Sleep Disordered Breathing","2026-06-29",{"date":93,"type":94},"2026-07-01","ACTUAL",{"date":96,"type":94},"2019-05-02",{"date":98,"type":81},"2027-03-31",{"name":5,"class":6},1]