[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lunair Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100611655","neurostimulation-for-sleep-disordered-breathing-sdb-100611655",false,"NCT07243405","Neurostimulation for Sleep Disordered Breathing (SDB)","The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing","ECLIPSE 2","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 judgement 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 the 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 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":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.",[27,28],"Sleep Disordered Breathing (SDB)","Sleep Apnea","RECRUITING","2025-11-17",{"date":32,"type":33},"2025-11-21","ACTUAL",{"date":35,"type":33},"2025-07-30",{"date":37,"type":21},"2027-12-31",{"name":39,"class":40},"Lunair Medical","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":41},"100574714","early-phase-1-assessment-of-osa-in-latin-american-and-response-to-neuromod-therapy-100574714","NCT06762873","Assessment of OSA in Latin American and Response to Neuromod Therapy","Assessment of Obstructive Sleep Apnea in the Latin American Population and Response to Neuromodulation Therapy to Treat Obstructive Sleep Apnea","Trans-Q DISE","Inclusion Criteria:\n\n1. Subject is aged ≥ 18 years old\n2. Subject is willing and able to provide informed consent\n3. Subject is geographically stable\n4. Subject does not have access to alternative Sleep Disordered Breathing treatments (e.g. oral appliances, and\u002For behavioral treatments)\n5. Subject has an Apnea-Hypopnea Index (AHI) score ≥15 \\\u003C 100 events per hour on Screening PSGs (under AASM 4%) based on in-lab polysomnography studies\n\nExclusion Criteria:\n\n1. Subject is currently implanted with another active implantable device.\n2. Subject is actively enrolled in another premarket investigational study (medical device or drug) unless approved by Sponsor in writing.\n3. Subject is considered vulnerable such as incarcerated or cognitively impaired.\n4. Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that in the opinion of the investigator may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.\n5. Any reason for which, in the judgment of the investigator, the subject is considered to be a poor study candidate, which may include, but is not limited to: any uncontrolled neurological, medical, social, or psychological problems that could complicate the required procedures and evaluations of the study ((e.g. uncontrolled hypertension, unstable angina, uncompensated heart failure or COPD, major depression, Parkinson's disease, epilepsy)\n6. Subject has previous upper respiratory tract (URT) surgery (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.\n7. Subject has a need for chronic supplemental oxygen therapy for any reason or a PaO2 \\\u003C70 mm Hg\n8. Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness and\u002For overnight PSG Study outcomes (e.g. Narcolepsy with cataplexy, idiopathic hypersomnolence, insomnia, REM sleep behavior disorder, or sleep movement disorders, such as restless leg syndrome or periodic limb movement, producing sleep disturbances unrelated to OSA.)\n9. Subject has severe chronic kidney disease (GFR \\\u003C 30)\n10. Subject has currently excessive use of alcohol, tobacco, caffeine, or recreational drugs.\n11. Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study.\n12. Subject has a BMI \\> 40 kg\u002Fm2\n13. Subject has an active systemic infection\n14. If female, subject is pregnant at the time of enrollment or planning to become pregnant during the study time period (must have a negative serum or urine pregnancy test within 14 days prior to enrollment)\n15. Subject has a tonsil size 3 or 4 based on the tonsil grading system\n16. Subject has documented history of Phrenic nerve palsy or asymmetry of the diaphragm\n17. Subject has any trauma to the upper airway that interferes with limited tongue movement or inability to move the tongue, tongue dysfunction, atrophy, hypertrophy, fasciculation, or problems swallowing or speaking\n18. Subject has severe mandibular deficiency\u002Fretrognathia or syndromic craniofacial abnormalities.\n19. Subject has previous surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.\n20. Subject has an oxygen saturation (SaO2) \\>10% falls index \\> 15 events per hour on Screening PSGs\n21. Subject has \\>25% central apnea events as a proportion of the sum of apnea and hypopnea events per hour on Screening PSGs (up to 3 patients with CAI+MAI ≥ 25% may be included)\n22. Subject has sleep Efficiency \\\u003C 80%",{"count":51,"type":21},50,[53],"EARLY_PHASE1","The purpose of this study is to characterize the upper airway of Latin American subjects who have been diagnosed with moderate\u002Fsevere obstructive sleep apnea (OSA) and assess response to a neuromodulation therapy to treat OSA.",[56],"Obstructive Sleep Apnea","2025-09-02",{"date":59,"type":33},"2025-09-03",{"date":61,"type":33},"2024-11-21",{"date":63,"type":21},"2025-12-31",{"name":39,"class":40},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":14,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":41},"100583998","neurostimulation-for-sleep-disordered-breathing-100583998","NCT06883617","Neurostimulation for 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.",{"count":20,"type":21},[24],"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.",[27,28],"2025-03-19",{"date":78,"type":33},"2025-03-20",{"date":80,"type":33},"2025-01-13",{"date":82,"type":21},"2027-12-15",{"name":39,"class":40},""]