Clinical Trial

Botulinum Toxin in the Palatopharyngeal Muscle for the Treatment of Obstructive Sleep Apnea

Study acronym: ARAP1
Not Yet Recruiting Phase 2
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Summary
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.
Trial Details
NCT Number NCT07399782
Lead Sponsor Hospital Felicio Rocho
Conditions Sleep Apnea Syndrome, Obstructive, Sleep Apnea Syndrome (OSAS), Sleep Apnea/Hypopnea Syndrome, Sleep Apnea - Obstructive
Enrollment 20 participants
Start Date 2026-04-05
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-10