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NCT Number: NCT07399782

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

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.

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Key information

Conditions

Sleep Apnea Syndrome, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea - Obstructive Sleep Apnea Syndrome (OSAS) Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Apnea/Hypopnea Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Apnea-Hypopnea Index (AHI)

    Time frame: 12 months

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

Secondary outcomes

  1. Minimum oxygen saturation (SpO₂)

    Time frame: 12 months

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

  2. Epworth Sleepiness Scale

    Time frame: 12 months

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

  3. Oxygen desaturation index (ODI).

    Time frame: 12 months

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

Other outcomes

  1. Adverse events

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alan Rodrigues Paiva, MSc

CONTACT

[email protected]

+55 31 9 96869586

Sponsors and collaborators

Lead sponsor

Hospital Felicio Rocho

Other

Registry information

Official study title

EVALUATION OF BOTULINUM TOXIN IN THE PALATOPHARYNGEAL MUSCLE FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA

Acronym: ARAP1

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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