[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,79,105],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100648209","clinical-trial-of-the-cryosa-system-for-the-treatment-of-obstructive-sleep-apnea-oasis-100648209",false,"NCT07720219","Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (OASIS)","Obstructive Sleep Apnea Severity Reduction by AdIpose CryolysiS","(OASIS)","Inclusion Criteria:\n\n1. Participant age is 22 years and older\n2. Participant has failed, is unable to use, unwilling to use or dissatisfied with Positive Airway Pressure (PAP) or mandibular advancement devices (MAD)\n3. Participant is diagnosed with Obstructive Sleep Apnea with an AHI ≥30 OR AHI ≥ 15 and BMI of ≥ 30 at enrollment (CA\u002FMA ≤ 25%)\n4. Participant is willing and capable of receiving the study procedure, completing all the questionnaires and returning for all follow-up evaluations and sleep studies\n5. Participant is willing and capable of providing informed consent\n\nExclusion Criteria:\n\n1. Participant is currently participating in other premarket investigational studies unless approved by Sponsor in writing\n2. Any reason for which, in the judgment of the investigator, the participant 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 Type 1 or 2 diabetes with neuropathy, debilitating acute or chronic cardiac, lung, liver, kidney, central nervous system or psychiatric disease)\n3. Participant has a BMI \\> 40 kg\u002Fm2 at enrollment\n4. Women who are pregnant or of childbearing potential (WOCBP defined as fertile following menarche and until becoming post-menopausal unless permanently sterile) who are unwilling to practice an appropriate method of contraception from screening through 6-month follow-up.\n\n   Concomitant Medication Exclusions\n5. Participant is actively taking ACEs\u002FARBs for hypertension AND is either of black race, of female gender, or \\>65 years of age\n6. Participant is actively undergoing immunotherapy (Allergy shots), and unwilling to wash out of allergy shots at least 2 weeks prior to study procedure\n7. Participant is taking any of the following medications that, in the opinion of the investigator, could affect study endpoints: AD109, benzodiazepines, Z-drugs (zolpidem and eszopiclone), opiates, antipsychotics (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi, Provigil, and Nuvigil)\n\n   Significant Airway Risk Factors\n8. Participants with severe uncontrolled asthma\n9. Participants with a history of angioedema\n10. Participants with hereditary angioedema (confirmed with a Complement Component C4 blood test \\\u003C13mg\u002FdL)\n11. Participant has uncontrolled autoimmune disorders including active thyroid disease, lupus, multiple myeloma, and chronic lymphocytic leukemia that could lead to acquired angioedema\n12. Participant has a history or presence of cold urticaria at the time of screening\n13. Participant has a history of cryoglobulinemia or Paradoxical Adipose Hyperplasia (PAH)\n14. Participant has a history of allergy to glycerin History of Oral\u002FAirway Comorbidities\u002FInterventions\n15. Participant has a prior airway interventions that alter or excise the tissue of the soft palate or the tongue base\n16. Participant has any airway intervention within 12 weeks of scheduled procedure performed to alter or excise the soft tissue of the airway or larynx\n17. Participant has an active, implanted, nerve stimulator for the treatment of OSA\n18. Participant has oral cancer or non-healing oral wounds\n19. Participant has a history of radiation therapy to neck or upper respiratory tract\n20. Participant has other severe sleep disorders that, in the opinion of the investigator, confound functional assessments of sleepiness such as narcolepsy with cataplexy, severe insomnia\u002Finsomnia secondary to chronic pain, PTSD\n\n    Major Anatomical Exclusions\n21. Participant has severe maxillary mandibular insufficiency or obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction) that, in the opinion of the investigator, is thought to be the primary cause of OSA\n22. Participant has obstructions identified at the tonsils (palatine tonsils size 3+ or 4+)\n23. Participant has lingual tonsils size 4+\n24. Participant has Friedman tongue position IV\n25. Participant has a mandibular intermolar width \\\u003C 32mm\n26. Participant has trismus as defined by a maximal inter-incisal opening of \\\u003C 35mm\n\n    Significant Comorbidities that Contraindicate Surgery or General Anesthesia\n27. Participant has resistant hypertension, defined as a blood pressure that remains above goal despite concurrent use of three antihypertensive agents of different classes taken at maximally tolerated doses\n28. Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)\n29. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).\n30. Uncontrolled Diabetes (including Diabetes Mellitus \\[DM\\] or Insulin Dependent Diabetes Mellitus \\[IDDM\\]) with HbA1c \\>9 at time of screening.\n31. Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (\\\u003C 12 months) myocardial infarction or severe cardiac arrhythmias\n32. Participants with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months\n33. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months\n34. Participant has contraindication to general anesthesia or, in the opinion of the Investigator, would not be able to tolerate the procedure, including intubation during the procedure\n\n    Lifestyle considerations\n35. Participant is a current smoker or nicotine vaper (\\>1 pack\u002Fday or equivalent)\n36. Participant conducts work or regular activities requiring vigilance (e.g., commercial driver, heavy machine operator, shift worker, etc.) that does not accommodate untreated OSA.\n37. Participant has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG\n38. Participant exhibits ongoing misuse of alcohol or recreational drugs that would impact either the results of or the participation in a sleep study","ALL","22 Years",{"count":20,"type":21},130,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this study is to evaluate the safety and effectiveness of the Cryosa System when used as intended to perform the Cryosa Procedure.",[27,28,29],"Obstructive Sleep Apnea (OSA)","Sleep Apnea - Obstructive","OSA",[31,32,29,33,34],"OASIS","Crysoa","Cryotherapy","Obstructive Sleep Apnea","NOT_YET_RECRUITING","2026-07-16",{"date":38,"type":39},"2026-07-22","ACTUAL",{"date":41,"type":21},"2026-10",{"date":43,"type":21},"2029-11",{"name":45,"class":46},"Cryosa, Inc.","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100639491","splintless-versus-conventional-maxillomandibular-advancement-surgery-for-obstructive-sleep-apnea-100639491","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.","18 Years",{"count":57,"type":21},66,[24],"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.",[61,62,28],"Sleep Apnea Syndrome (OSAS)","Orthognathic Surgical Procedures",[29,64,65,66,67],"Maxilomandibular advancement surgery","MMA","Patient-specific implants","Splintless orthognathic","2026-05-13",{"date":70,"type":39},"2026-05-20",{"date":72,"type":21},"2026-12-01",{"date":74,"type":21},"2033-02-28",{"name":76,"class":77},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":78},"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":87,"type":21},55,[24],"The goal of this study is to evaluate the effectiveness of the Elara APAP device.",[28],[29,92,93,94,34,95],"Sleep Apnea","APAP","Polysomnography","Sleep Study","2026-04-23",{"date":98,"type":39},"2026-04-30",{"date":100,"type":21},"2026-04-27",{"date":102,"type":21},"2026-06-30",{"name":104,"class":46},"Sleepnet Corporation",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"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":115,"type":21},20,[117],"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.",[120,61,121,28],"Sleep Apnea Syndrome, Obstructive","Sleep Apnea\u002FHypopnea Syndrome","2026-02-05",{"date":124,"type":39},"2026-02-10",{"date":126,"type":21},"2026-04-05",{"date":128,"type":21},"2026-09-01",{"name":130,"class":77},"Hospital Felicio Rocho"]