About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of moderate to severe OSA, confirmed by home or laboratory polysomnography.
Age between 18 and 50 years.
BMI in the range of 18.5-30.
Neck circumference ≤ 44 cm (men) and ≤ 42 cm (women).
Disqualifiers
Tonsillar hypertrophy 3-4
Obesity (BMI > 30 kg/m²)
Elderly (age > 50 years)
Neuromuscular diseases (e.g., dystrophies, myasthenia gravis)
Trial design
Single group
Treatments tested in this trial
BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE
DrugBotulinum 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.
Treatment groups
Trial outcomes
Primary outcomes
Apnea-Hypopnea Index (AHI)
Evaluate the variation in the Apnea-Hypopnea Index (AHI) before and 3 months after the intervention.
Secondary outcomes
Minimum oxygen saturation (SpO₂)
Verify the impact of the intervention on minimum oxygen saturation (SpO₂)
Epworth Sleepiness Scale
Analyze the change in excessive daytime sleepiness, using the Epworth Sleepiness Scale, before and after the application of botulinum toxin.
Oxygen desaturation index (ODI).
Verify the impact of the intervention on oxygen desaturation index (ODI).
Other outcomes
Adverse events
Monitor the occurrence of adverse events related to the procedure and the application of the toxin, aiming to describe the safety profile of the intervention.
Locations
Sponsors and contacts
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