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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorHospital Felicio Rocho

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE

    Drug

    Botulinum 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

20 Participants
are divided into 1 treatment group
Group A: Botulinum toxinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Minimum oxygen saturation (SpO₂)

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

Time frame
12 months
2

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
3

Oxygen desaturation index (ODI).

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

Time frame
12 months

Other outcomes

1

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.

Time frame
12 months

Locations

This trial has no locations.

Sponsors and contacts

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