Sleep Apnea/Hypopnea Syndrome, Sleep Apnea - Obstructive, Sleep Apnea Syndrome, Obstructive, Sleep Apnea Syndrome (OSAS)
Conditions
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.
Interventions
DRUGBOTULINUM 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.
Sponsors
Hospital Felicio Rocho
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | 12 months | Evaluate the variation in the Apnea-Hypopnea Index (AHI) before and 3 months after the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimum oxygen saturation (SpO₂) | 12 months | Verify the impact of the intervention on minimum oxygen saturation (SpO₂) |
| Epworth Sleepiness Scale | 12 months | Analyze the change in excessive daytime sleepiness, using the Epworth Sleepiness Scale, before and after the application of botulinum toxin. |
| Oxygen desaturation index (ODI). | 12 months | Verify the impact of the intervention on oxygen desaturation index (ODI). |
Contacts
CONTACTAlan Rodrigues Paiva, MSc
Outcome results
None listed