[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512527":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":68,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":24,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":82,"maxAge":24,"enrollmentInfo":83,"targetDuration":24,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"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",[36,55],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"UCLA Santa Monica Medical Center","RECRUITING","Santa Monica","California","90401","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-118.49138,34.01949,{"lat":48,"lon":47},[51,53],{"name":52,"role":32,"phone":24,"phoneExt":24,"email":24},"Eric Kezirian, MD, MPH",{"name":52,"role":54,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"facility":56,"status":57,"city":58,"state":40,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"UCLA Westwood","NOT_YET_RECRUITING","Westwood, Los Angeles","90095",{"type":45,"coordinates":61},[62,63],-118.43063,34.05612,{"lat":63,"lon":62},[66,67],{"name":52,"role":32,"phone":24,"phoneExt":24,"email":24},{"name":52,"role":54,"phone":24,"phoneExt":24,"email":24},{"type":54,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Eric J. Kezirian, MD, MPH","Professor",[72],{"name":73,"class":74},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100512527","phase-2-endotypic-traits-and-obstructive-sleep-apnea-surgery-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":84,"type":85},150,"ESTIMATED","INTERVENTIONAL",[88],"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).",[91],"Obstructive Sleep Apnea",[93,94,95],"surgery","loop gain","arousal threshold","2026-06-29",{"date":98,"type":99},"2026-07-01","ACTUAL",{"date":101,"type":99},"2024-01-07",{"date":103,"type":85},"2028-08-31",{"name":5,"class":6},2]