[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512527":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":67,"collaborators":70,"id":74,"slug":24,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":24,"eligibilityCriteria":78,"healthyVolunteers":75,"sex":79,"minAge":80,"maxAge":24,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acetazolamide","EXPERIMENTAL","Treatment with acetazolamide 500 mg nightly for 1 month.",[13],"Drug: Acetazolamide 500 MG QHS",{"label":15,"type":10,"description":16,"interventionNames":17},"Acetazolamide\u002FEszopiclone","Treatment with acetazolamide 500 mg and eszopiclone 3 mg nightly for 1 month.",[13,18],"Drug: Eszopiclone 3 mg QHS",[20,25],{"type":21,"name":22,"description":9,"armGroupLabels":23,"otherNames":24},"DRUG","Acetazolamide 500 MG QHS",[9,15],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Eszopiclone 3 mg QHS","Eszopiclone",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Eric J Kezirian, MD, MPH","CONTACT","32344257904242596559","EKezirian@mednet.ucla.edu",[36,54],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"UCLA Santa Monica Medical Center","RECRUITING","Santa Monica","California","90401","United States",{"type":44,"coordinates":45},"Point",[46,47],-118.49138,34.01949,{"lat":47,"lon":46},[50,52],{"name":51,"role":32,"phone":24,"phoneExt":24,"email":24},"Eric Kezirian, MD, MPH",{"name":51,"role":53,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"facility":55,"status":56,"city":57,"state":40,"zip":58,"country":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"UCLA Westwood","NOT_YET_RECRUITING","Westwood, Los Angeles","90095",{"type":44,"coordinates":60},[61,62],-118.43063,34.05612,{"lat":62,"lon":61},[65,66],{"name":51,"role":32,"phone":24,"phoneExt":24,"email":24},{"name":51,"role":53,"phone":24,"phoneExt":24,"email":24},{"type":53,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Eric J. Kezirian, MD, MPH","Professor",[71],{"name":72,"class":73},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100512527",false,"NCT05953610","Endotypic Traits and Obstructive Sleep Apnea Surgery","Inclusion criteria are:\n\n1. age ≥21 years;\n2. moderate to severe OSA (obstructive AHI ≥ 15 events\u002Fhour);\n3. central\u002Fmixed apnea index \\\u003C5 events\u002Fhour;\n4. intolerance of positive airway pressure (defined as use \\\u003C 2 hours\u002Fnight at least 5 nights\u002Fweek);\n5. intolerance or poor candidate for oral appliance;\n6. participant has provided informed consent for palate surgery as part of their standard of care;\n7. tonsil size 0-2+ (without markedly enlarged tonsils that have high surgical success rates);\n8. DISE without evidence of complete tongue-related obstruction (reflecting poorer results with isolated palate surgery);\n9. medications stable for ≥2 months;\n10. body mass index \\\u003C35 kg\u002Fm2;\n11. absence of uncontrolled nasal obstruction;\n12. no prior pharyngeal surgery other than tonsillectomy;\n13. no neurologic, cardiac or pulmonary disorders;\n14. absence of psychiatric disorder except for treated depression or mild anxiety;\n15. no co-existing sleep disorder, such as narcolepsy, chronic insomnia, or restless legs syndrome;\n16. no use of hypnotics, anxiolytics, stimulants, or sedating antidepressants;\n17. no near-miss or prior motor vehicle crash due to sleepiness in past 12 months; and\n18. \\\u003C3 caffeinated beverages daily.\n\nExclusion criteria are:\n\n1. history of allergic reaction to either of the study drugs;\n2. subjects with prior serious allergic reaction (such as Stevens-Johnson syndrome) to sulfonamides;\n3. subjects with a history of hypersensitivity to either of the two study drugs;\n4. subjects who are on high-dose aspirin therapy due to risk of severe metabolic acidosis;\n5. subjects with severe kidney disease or severe liver disease;\n6. subjects with a history of electrolyte imbalance or adrenal insufficiency (due to risks related to acetazolamide);\n7. subjects on ketoconazole or other strong CYP3A4 inhibitors (these will increase eszopiclone blood levels);\n8. pregnancy; and\n9. alcohol or substance abuse.","ALL","21 Years",{"count":82,"type":83},150,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","This study will examine factors associated with outcomes after soft palate surgery and medications (acetazolamide, eszopiclone) that may treat other potential causes of obstructive sleep apnea (loop gain, arousal threshold).",[89],"Obstructive Sleep Apnea",[91,92,93],"surgery","loop gain","arousal threshold","2026-06-29",{"date":96,"type":97},"2026-07-01","ACTUAL",{"date":99,"type":97},"2024-01-07",{"date":101,"type":83},"2028-08-31",{"name":5,"class":6},2]