[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571460":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":12,"centralContacts":23,"locations":29,"responsibleParty":49,"collaborators":52,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":12,"enrollmentInfo":70,"targetDuration":12,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":32,"whyStopped":12,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Columbia University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Therapeutic HGNS (HGNS-on)","NO_INTERVENTION","Prior to enrollment in this study, participants will have been implanted with and stabilized on HGNS therapy. As part of clinical care, a therapeutic voltage setting will have been confirmed via overnight sleep study. This arm of the study maintains the participants on the HGNS therapy at the therapeutic voltage they have been using. This is a representation of the patient's baseline status.",null,{"label":14,"type":6,"description":15,"interventionNames":16},"No HGNS therapy (HGNS-off)","HGNS therapy will be turned off by the participant for this arm of the study. This arm will mimic the participant's untreated OSA statement before they had HGNS therapy activated.",[17],"Device: No HGNS therapy (HGNS-off)",[19],{"type":20,"name":14,"description":21,"armGroupLabels":22,"otherNames":12},"DEVICE","Prior to enrollment in this study, participants will have been utilizing HGNS at a therapeutic voltage setting confirmed via overnight sleep study. As part of the trial, they will undergo a study arm that involves turning off HGNS therapy (HGNS-off) for between 2-4 weeks.",[14],[24],{"name":25,"role":26,"phone":27,"phoneExt":12,"email":28},"Otolaryngology Research Group","CONTACT","646-317-3252","otosleepresearch@cumc.columbia.edu",[30],{"facility":31,"status":32,"city":33,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Columbia University Medical Center","RECRUITING","New York","10032","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-74.00597,40.71427,{"lat":41,"lon":40},[44,46],{"name":45,"role":26,"phone":27,"phoneExt":12,"email":28},"Jesus Lopez",{"name":47,"role":48,"phone":12,"phoneExt":12,"email":12},"Yi Cai, M.D.","PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Yi Cai","Director of Sleep Surgery",[53,55,58],{"name":54,"class":6},"American Academy of Sleep Medicine",{"name":56,"class":57},"Triological Society","UNKNOWN",{"name":59,"class":6},"American Heart Association","100571460","cardiometabolic-risk-effects-of-short-term-cessation-of-neurostimulation-therapy-100571460",false,"NCT06720545","Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy","Cardiometabolic Risk Effects of Short-term Cessation of Effective Neurostimulation Therapy in OSA","CRESCENT","Inclusion Criteria:\n\n* English-speaking adults (18+ years) who have met surgical efficacy criteria with HGNS, as defined by at least a 50% reduction in apnea-hypopnea index (AHI) to \\\u003C20 (with hypopneas defined by 4% oxyhemoglobin desaturations)\n* Have been using HGNS therapy for at least 3 months and used HGNS for \\>20 hours\u002Fweek during the past 4 weeks\n* Were not using any OSA therapy for at least one month prior to HGNS activation or have had a one-month period of untreated OSA after HGNS activation\n\nExclusion Criteria:\n\n* Chronic use of opiate medications, illicit drugs, or alcohol dependency\n* Women who are pregnant or planning to become pregnant\n* Shift workers, heavy machinery operators, or commercial drivers\n* History of severe excessive daytime sleepiness (Epworth Sleepiness Scale score \\>16 at time of screening or prior to HGNS), motor vehicle accidents or near-miss incidents due to drowsy driving within the year prior to enrollment\n* Significant cardiopulmonary (such as home oxygen requirement), liver, renal, or oncologic disease; neurodegenerative disease; active or recent history of an eating disorder (within the last 5 years)\n* Inability to provide informed consent","ALL","18 Years",{"count":71,"type":72},60,"ESTIMATED","INTERVENTIONAL",[75],"NA","Hypoglossal nerve stimulation (HGNS) is an implantable therapy that treats obstructive sleep apnea.\n\nThe study will evaluate the effect of this treatment on cardiovascular and metabolism-related measures to see if it affects patients' risk of medical problems associated with obstructive sleep apnea (OSA).",[78,79],"Obstructive Sleep Apnea","Obstructive Sleep Apnea of Adult",[81,82],"hypoglossal nerve stimulation","inspire","2025-07-05",{"date":85,"type":86},"2025-07-10","ACTUAL",{"date":88,"type":86},"2025-01-05",{"date":90,"type":72},"2028-01",{"name":5,"class":6},1]