Botulinum Toxin in the Palatopharyngeal Muscle for the Treatment of Obstructive Sleep Apnea (ARAP1)

February 5, 2026 updated by: Alan Rodrigues de Almeida Paiva, Hospital Felicio Rocho

EVALUATION OF 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum toxin
BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE
Drug: BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index (AHI)
Time Frame: 12 months
Evaluate the variation in the Apnea-Hypopnea Index (AHI) before and 3 months after the intervention.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimum oxygen saturation (SpO₂)
Time Frame: 12 months
Verify the impact of the intervention on minimum oxygen saturation (SpO₂)
12 months
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.
12 months
Oxygen desaturation index (ODI).
Time Frame: 12 months
Verify the impact of the intervention on oxygen desaturation index (ODI).
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Felicio Rocho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 5, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 2, 2025

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90369725.9.0000.5125
  • 121415 (Other Identifier: Hospital Felicio Rocho)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Age, Weight, Height, Sex, Test Results, Questionnaire Results, Contact Telephone Number, Intervention Location, Information on Procedures, Procedure Videos

IPD Sharing Time Frame

From the beginning to the end of the study

IPD Sharing Access Criteria

Contact the principal investigator via email or phone

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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