EVALUATION OF BOTULINUM TOXIN IN THE PALATOPHARYNGEAL MUSCLE FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Neck circumference ≤ 44 cm (men) and ≤ 42 cm (women).
- •Absence of signs of upper obstruction
排除标准
- •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.
研究组 & 干预措施
Botulinum toxin
BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE
干预措施: BOTULINUM TOXIN IN THE PALATOPHARYGEUS MUSCLE (Drug)
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: 12 months
Evaluate the variation in the Apnea-Hypopnea Index (AHI) before and 3 months after the intervention.
次要结局
- Minimum oxygen saturation (SpO₂)(12 months)
- Epworth Sleepiness Scale(12 months)
- Oxygen desaturation index (ODI).(12 months)
研究者
Alan Rodrigues de Almeida Paiva
Alan Rodrigues de Almeida Paiva
Hospital Felicio Rocho