[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583998":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":11,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":11,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Lunair Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Alpha Lunair System implanted subjects","EXPERIMENTAL",null,[13],"Device: Neuro stimulator Implant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Neuro stimulator Implant","Neuro Stimulator for treating sleep disordered breathing",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Andrea Director of Clinical Operations","CONTACT","1-866-675-4430","andreas@lunairmedical.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Sanatorio Americano","RECRUITING","Asunción","Paraguay","PY",{"type":34,"coordinates":35},"Point",[36,37],-57.647,-25.28646,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":42,"phoneExt":11,"email":25},"Santos, MD","866-675-4430",{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100583998","neurostimulation-for-sleep-disordered-breathing-100583998",false,"NCT06883617","Neurostimulation for Sleep Disordered Breathing","The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing","ECLIPSE 1","Inclusion Criteria:\n\n* Subject does not tolerate, not compliant to or have access to alternative Sleep Disordered Breathing treatments\n* Subject has moderate to severe sleep disordered breathing as diagnosed by PSG\n\nExclusion Criteria:\n\n* Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.\n* Any reason for which, in the judgment of the investigator, the subject is considered to be a poor study candidate\n* Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.\n* Subject has a need for chronic supplemental oxygen therapy for any reason\n* Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness\n* Subject has severe chronic kidney disease\n* Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that would impact either the results of or the participation in a sleep study.\n* Subject conducts work or regular activities requiring vigilance\n* Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study.\n* Subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices\n* Subject has an active systemic infection at time of implant.\n* Subject has clinical evidence of immunodeficiency.\n* Any condition likely to require future MRI or diathermy\n* Subject is pregnant\n* Subject has a severe nasal obstruction that could restrict airflow\n* Subject has any trauma to the upper airway\n* Subject has previous surgical resection, prior or current radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.","ALL","18 Years",{"count":56,"type":57},45,"ESTIMATED","INTERVENTIONAL",[60],"NA","This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.",[63,64],"Sleep Disordered Breathing (SDB)","Sleep Apnea","2025-03-19",{"date":67,"type":68},"2025-03-20","ACTUAL",{"date":70,"type":68},"2025-01-13",{"date":72,"type":57},"2027-12-15",{"name":5,"class":6},1]