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

NCT07399782 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: 90369725.9.0000.5125121415
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sleep Apnea Syndrome, Obstructive; Sleep Apnea Syndrome (OSAS); Sleep Apnea/Hypopnea Syndrome; Sleep Apnea - Obstructive

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

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

  12 months

Secondary Outcomes (3)

• Minimum oxygen saturation (SpO₂)

  12 months

• Epworth Sleepiness Scale

  12 months

• Oxygen desaturation index (ODI).

  12 months

Other Outcomes (1)

• Adverse events

  12 months

Study Arms (1)

Botulinum toxin

EXPERIMENTAL

BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE

Drug: BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE

Interventions

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.

Botulinum toxin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Hospital Felicio Rocho: lead

Related Publications (2)

• Swislocki ALM, Eisenberg ML. Peyronie Disease as a Marker of Inflammation-Is There Hope on the Horizon? Am J Med. 2021 Oct;134(10):1218-1223. doi: 10.1016/j.amjmed.2021.06.015. Epub 2021 Jul 14.

  PMID: 34273285 BACKGROUND

• Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. Physiol Rev. 2010 Jan;90(1):47-112. doi: 10.1152/physrev.00043.2008.

  PMID: 20086074 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Alan Rodrigues Paiva, MSc

CONTACT

+55 31 9 96869586; alanrodriguesmd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alan Rodrigues de Almeida Paiva

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: February 10, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From the beginning to the end of the study
• Access Criteria: Contact the principal investigator via email or phone