Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy Among Obstructive Sleep Apnea Subjects Referred for Surgical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- The VOTE Endoscopic Classification
研究概览
简要总结
Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea (OSA). However, there are no studies comparing DISE to sleep endoscopy during natural sleep. Objectives: To compare DISE to natural sleep endoscopy in OSA patients referred for surgical treatment.
Methods: OSA patients referred to surgical treatment (lateral pharyngoplasty) will be enrolled in this study. Natural sleep endoscopy will be performed at the sleep lab during the night. Propofol induced sleep will be performed at the operating room before surgery. The VOTE (velum, oropharyngeal lateral walls, tongue base and epiglottis) classification will be used to compare site and configuration of collapse between studies. Peak inspiratory flow will also be compared between studies.
详细描述
Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea. However, there are no studies comparing DISE to sleep endoscopy during natural sleep. Objective: to compare natural sleep endoscopy to drug induced sleep with propofol.
The study population will include 28 patients who are candidates to surgical treatment.
Methods Detailed clinical history and physical examination will be performed before natural sleep endoscopy. A 2-hour fast will be required. During both natural sleep and propofol-induced sleep, pharyngeal pressure will be measured using a pressure-tipped catheter (model TC-500XG; Millar).The nasopharynx will be numbed with xylocaine (10%) and oxymetazoline (0.05%), the catheter will be passed through a nasal mask into one nostril, and placed at the tongue base as confirmed by visual inspection of the oropharynx.A 2.8mm pediatric bronchoscope (Olympus) will be passed through the mask and into the other nostril. A nasal mask will be fitted and a heated pneumotachograph with differential pressure transducer connected to the mask will quantify airflow. The endoscope will be located at velopharynx, lateral wall of the pharynx and 2 cm above tongue and epiglottis.The VOTE Endoscopic Classification will be used to describe site and configuration of pharyngeal collapse in each study. The study will be scored by two experienced investigators, blind to the patient identification and type of study (natural sleep or drug-induced). Propofol-induced sleep will be performed at the operating room before surgery.
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
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI less than 35kg/m2
- •Apnea-hypopnea index > 5 events/hour of sleep
- •Clinical indication of surgical treatment for sleep apnea
排除标准
- •Severe or decompensated cardiac or respiratory diseases
- •Previous pharyngeal surgery
- •Tonsils grade III or IV
- •Other sleep disturbance (parasomnias, primary insomnia, narcolepsy)
- •Sedative medication use (opioids, benzodiazepines and muscle relaxants)
- •Uncontrolled diabetes or hyperthyroidism
研究组 & 干预措施
Natural Sleep
OSA subjects referred for surgical treatment will evaluated endoscopically during natural sleep
Propofol Induced Sleep
Sleep endoscopy during propofol induced sleep
OSA subjects referred for surgical treatment will be evaluated endoscopically during propofol induced sleep
干预措施: Sleep endoscopy during propofol induced sleep (Other)
结局指标
主要结局
The VOTE Endoscopic Classification
时间窗: Immediately, during the procedure
Comparison of site and configuration of endoscopy findings between the natural and drug-induced sleep endoscopy. The VOTE Endoscopic Classification describes the patterns and the degree of obstruction during sleep endoscopy.
次要结局
- Peak inspiratory flow(Immediately, during the procedure)
研究者
Pedro Rodrigues Genta
Principal Investigator
University of Sao Paulo General Hospital
