[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623680":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":35,"eligibilityCriteria":36,"healthyVolunteers":31,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":19,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":19,"overallStatus":52,"whyStopped":19,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":19},{"fullName":5,"class":6},"Hospital Felicio Rocho","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Botulinum toxin","EXPERIMENTAL","BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE",[13],"Drug: BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Botulinum toxin will be injected into the palatopharyngeal muscle in patients undergoing Medication-Induced Sleep Endoscopy. The injection will be performed while visualizing the posterior pharyngeal constriction.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Alan Rodrigues Paiva, MSc","CONTACT","+55 31 9 96869586","alanrodriguesmd@gmail.com",{"type":27,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Alan Rodrigues de Almeida Paiva","100623680","phase-2-botulinum-toxin-in-the-palatopharyngeal-muscle-for-the-treatment-of-obstructive-sleep-apnea-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":41,"type":42},20,"ESTIMATED","INTERVENTIONAL",[45],"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.",[48,49,50,51],"Sleep Apnea Syndrome, Obstructive","Sleep Apnea Syndrome (OSAS)","Sleep Apnea\u002FHypopnea Syndrome","Sleep Apnea - Obstructive","NOT_YET_RECRUITING","2026-02-05",{"date":55,"type":56},"2026-02-10","ACTUAL",{"date":58,"type":42},"2026-04-05",{"date":60,"type":42},"2026-09-01",{"name":5,"class":6}]