[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-apnea---obstructive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-apnea---obstructive":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,77],{"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":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100639491","splintless-versus-conventional-maxillomandibular-advancement-surgery-for-obstructive-sleep-apnea-100639491",false,"NCT07598461","Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea","Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea: a Randomized Controlled Trial","SvCMAS","Inclusion Criteria:\n\nFor OSA patients:\n\n* Adults aged 18 years or older;\n* Moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15 events\u002Fhour) as determined by an overnight polysomnography (PSG) preoperatively;\n* Continunous positive airway pressure failure or intolerance;\n* General good health for surgery;\n* MMA surgery indicated for OSA treatment.\n\nFor bedpartners of patients:\n\n• Sharing a bed ⩾2 nights\u002Fweek with patient.\n\nExclusion Criteria:\n\nFor OSA patients:\n\n* Other adjunctive procedures indicated at the time of MMA (e.g., multi-piece Le Fort I osteotomy, temporomandibular joint reconstruction);\n* Previous history of orthognathic surgery;\n* Cleft palate and syndromic patients;\n* Refusal to participate.\n\nFor bedpartners of patients:\n\n• Refusal to participate.","ALL","18 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to find out whether using a splintless surgical approach improves the accuracy of maxillomandibular advancement (MMA) surgery for treating obstructive sleep apnea (OSA) in adults. The study will also look at the safety, functional outcomes, and cost-effectiveness of the splintless approach. The main questions it aims to answer are:\n\nDoes the splintless approach lead to more accurate surgical movements of the jaws compared to the conventional splint-based method? What are the safety profile, functional outcomes, and cost-effectiveness of the splintless approach?\n\nResearchers will compare splintless MMA to conventional MMA.\n\nPatients will:\n\nUndergo MMA surgery using either the splintless or splint-based method; Attend regular follow-up visits as part of routine care; Complete questionnaires and undergo assessments at various time points; Receive one additional CT scan (24 months after surgery) and one overnight sleep study (60 months after surgery).\n\nBedpartners of patients will:\n\nComplete questionnaires at various time points.\n\nThis trial will help determine whether the splintless approach is a better, safer, and more effective alternative for treating OSA with MMA surgery.",[27,28,29],"Sleep Apnea Syndrome (OSAS)","Orthognathic Surgical Procedures","Sleep Apnea - Obstructive",[31,32,33,34,35],"OSA","Maxilomandibular advancement surgery","MMA","Patient-specific implants","Splintless orthognathic","NOT_YET_RECRUITING","2026-05-13",{"date":39,"type":40},"2026-05-20","ACTUAL",{"date":42,"type":21},"2026-12-01",{"date":44,"type":21},"2033-02-28",{"name":46,"class":47},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":48},"100635978","a-study-of-the-sleepnet-elara-apap-device-100635978","NCT07559708","A Study of the Sleepnet Elara APAP Device","A Prospective, Open-label Study to Assess the Efficacy of the Elara APAP Device When Used in Patients With Obstructive Sleep Apnea","Inclusion Criteria:\n\n1. Body weight ≥ 30kg\n2. Willing and able to consent, adhere to study requirements and receive mask treatment\n3. ≥ 18 years of age\n4. Diagnosed with OSA (Total AHI \\>15 events\u002Fhr) by a practicing physician within the last 6 months. A re-diagnosis may be necessary to establish current baseline AHI in case there has been significant weight change or other co-morbidities since the previous diagnosis (per PI discretion)\n5. Currently utilizing an APAP Device for ongoing treatment of OSA\n\nExclusion Criteria:\n\n1. Body weight \\\u003C 30kg\n2. Female currently bearing a child or intending to become pregnant prior to the sleep study.\n3. Have implanted pacemaker, ICD or any other medical device that would interfere with the PSG results or safety of the subject undergoing the study\n4. Has pneumothorax, pneumomediastinum\n5. Has history of Cerebrospinal fluid leakage, craniocerebral trauma, intracranial trauma or pneumocephalus\n6. Ongoing shock from various causes untreated\n7. Current epistaxis\n8. Non-compliant with APAP usage (\\\u003C 4 hours per night on 70% of nights)\n9. Upper gastrointestinal bleeding that has not been effectively controlled\n10. Has obstructive vocal cord polyps\n11. Severe coronary heart disease with left heart failure\n12. Acute otitis media inflammation (must be resolved prior to sleep study)\n13. Excessive respiratory secretions and cough weakness\n14. Weak spontaneous breathing\n15. Tracheal intubation (nasal or oral) and tracheotomy\n16. Severe nasal congestion from various causes\n17. Lung bullae\n18. Central sleep apnea index \\>5 events\u002Fhr\n19. Have another significant sleep disorder(s) that in the opinion of the investigator would confound the results of the study (e.g. periodic leg movements \\>15\u002Fhr or insomnia that would interfere with completing the sleep study).",{"count":57,"type":21},55,[24],"The goal of this study is to evaluate the effectiveness of the Elara APAP device.",[29],[31,62,63,64,65,66],"Sleep Apnea","APAP","Polysomnography","Obstructive Sleep Apnea","Sleep Study","2026-04-23",{"date":69,"type":40},"2026-04-30",{"date":71,"type":21},"2026-04-27",{"date":73,"type":21},"2026-06-30",{"name":75,"class":76},"Sleepnet Corporation","INDUSTRY",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100623680","phase-2-botulinum-toxin-in-the-palatopharyngeal-muscle-for-the-treatment-of-obstructive-sleep-apnea-100623680","NCT07399782","Botulinum Toxin in the Palatopharyngeal Muscle for the Treatment of Obstructive Sleep Apnea","EVALUATION OF BOTULINUM TOXIN IN THE PALATOPHARYNGEAL MUSCLE FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA","ARAP1","Inclusion Criteria:\n\n* Diagnosis of moderate to severe OSA, confirmed by home or laboratory polysomnography.\n* Age between 18 and 50 years.\n* BMI in the range of 18.5-30.\n* Neck circumference ≤ 44 cm (men) and ≤ 42 cm (women).\n* Absence of signs of upper obstruction\n\nExclusion Criteria:\n\n* Skeletal or craniofacial disorders:\n* Tonsillar hypertrophy 3-4\n* Obesity (BMI \\> 30 kg\u002Fm²)\n* Elderly (age \\> 50 years)\n* Neuromuscular diseases (e.g., dystrophies, myasthenia gravis)\n* Chronic use of medications that alter muscle tone.\n* Excessive alcohol consumption (\\> 14 drinks\u002Fweek)\n* Chronic obstructive pulmonary disease (COPD)\n* Congestive heart failure (NYHA III-IV) or decompensated heart disease.\n* Concomitant sleep disorders: narcolepsy, restless legs syndrome, sleep behavior disorder (REM).\n* Predominant central or mixed sleep apnea on polysomnography (≥ 50% central events).\n* Previous airway surgery (uvulopalatopharyngoplasty, recent tonsillectomy).\n* Pregnancy or postpartum (\\\u003C 6 months).\n* Neurological conditions: Previous stroke, Parkinson's disease, dementia.","50 Years",{"count":87,"type":21},20,[89],"PHASE2","Obstructive Sleep Apnea (OSA) is a sleep-related breathing disorder characterized by recurrent collapse of the upper airway during sleep, in which the palatopharyngeal muscle plays a key role in pathophysiology. Although continuous positive airway pressure (CPAP) remains the standard treatment, adherence is often suboptimal. Botulinum toxin type A (BoNT-A), a peripheral neuromodulator, has been proposed as a potential therapeutic alternative by inducing chemodenervation and muscle volume reduction, thereby potentially increasing upper airway patency. This study aims to evaluate the efficacy and safety of BoNT-A injection into the palatopharyngeal muscle in patients with moderate to severe OSA. This is a prospective, single-arm, interventional clinical trial with pre- and post-intervention assessment. We hypothesize that the intervention will result in a significant reduction in the Apnea-Hypopnea Index (AHI), along with improvements in secondary outcomes such as excessive daytime sleepiness and oxygenation parameters.",[92,27,93,29],"Sleep Apnea Syndrome, Obstructive","Sleep Apnea\u002FHypopnea Syndrome","2026-02-05",{"date":96,"type":40},"2026-02-10",{"date":98,"type":21},"2026-04-05",{"date":100,"type":21},"2026-09-01",{"name":102,"class":47},"Hospital Felicio Rocho"]