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

Study acronym: ARAP1
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 10, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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
(from sponsor)
Sleep Apnea Syndrome, Obstructive, Sleep Apnea Syndrome (OSAS), Sleep Apnea/Hypopnea Syndrome, Sleep Apnea - Obstructive
Related terms Sleep Apnea Syndromes, Sleep Apnea, Obstructive
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov