Botulinum Toxin in the Palatopharyngeal Muscle for the Treatment of Obstructive Sleep Apnea
Starting soon · Phase 2
Conditions studied: Sleep Apnea Syndrome, Obstructive, Sleep Apnea Syndrome (OSAS), Sleep Apnea/Hypopnea Syndrome, Sleep Apnea - Obstructive
In brief
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.
Key facts
- Study ID
- NCT07399782
- Run by
- Hospital Felicio Rocho
- People needed
- 20
- Starts
- 2026-04-05
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-02-10
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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