[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sleep-apneahypopnea-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sleep-apneahypopnea-syndrome":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100623680",false,"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.","ALL","18 Years","50 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Sleep Apnea Syndrome, Obstructive","Sleep Apnea Syndrome (OSAS)","Sleep Apnea\u002FHypopnea Syndrome","Sleep Apnea - Obstructive","NOT_YET_RECRUITING","2026-02-05",{"date":34,"type":35},"2026-02-10","ACTUAL",{"date":37,"type":21},"2026-04-05",{"date":39,"type":21},"2026-09-01",{"name":41,"class":42},"Hospital Felicio Rocho","OTHER",""]