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

Phase 2Not Yet RecruitingNCT07399782

Hospital Felicio Rocho20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sleep Apnea Syndrome, Obstructive Sleep Apnea Syndrome (OSAS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). * Absence of signs of upper obstruction Exclusion Criteria: * Skeletal or craniofacial disorders: * Tonsillar hypertrophy 3-4 * Obesity (BMI \> 30 kg/m²) * Elderly (age \> 50 years) * Neuromuscular diseases (e.g., dystrophies, myasthenia gravis) * Chronic use of medications that alter muscle tone. * Excessive alcohol consumption (\> 14 drinks/week) * Chronic obstructive pulmonary disease (COPD) * Congestive heart failure (NYHA III-IV) or decompensated heart disease. * Concomitant sleep disorders: narcolepsy, restless legs syndrome, sleep behavior disorder (REM). * Predominant central or mixed sleep apnea on polysomnography (≥ 50% central events). * Previous airway surgery (uvulopalatopharyngoplasty, recent tonsillectomy). * Pregnancy or postpartum (\< 6 months). * Neurological conditions: Previous stroke, Parkinson's disease, dementia.

Outcomes

Primary Outcomes

Apnea-Hypopnea Index (AHI)

Evaluate the variation in the Apnea-Hypopnea Index (AHI) before and 3 months after the intervention.

Time frame: 12 months

Secondary Outcomes

Minimum oxygen saturation (SpO₂)

Verify the impact of the intervention on minimum oxygen saturation (SpO₂)

Time frame: 12 months

Epworth Sleepiness Scale

Analyze the change in excessive daytime sleepiness, using the Epworth Sleepiness Scale, before and after the application of botulinum toxin.

Time frame: 12 months

Oxygen desaturation index (ODI).

Verify the impact of the intervention on oxygen desaturation index (ODI).

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts