Botulinum Toxin in the Palatopharyngeal Muscle for the Treatment of Obstructive Sleep Apnea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE.
- Who it may be relevant to
- Registry conditions: Sleep Apnea Syndrome, Obstructive, Sleep Apnea Syndrome (OSAS), Sleep Apnea/Hypopnea Syndrome, Sleep Apnea - Obstructive. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
EVALUATION OF BOTULINUM TOXIN IN THE PALATOPHARYNGEAL MUSCLE FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA
Overview
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.
Interventions
- 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.
Primary outcome measures
- Apnea-Hypopnea Index (AHI) [Time frame: 12 months]
Secondary outcome measures (3)
- Minimum oxygen saturation (SpO₂) [Time frame: 12 months]
- Epworth Sleepiness Scale [Time frame: 12 months]
- Oxygen desaturation index (ODI). [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
Identifiers
NCT: NCT07399782 · 90369725.9.0000.5125 · 121415