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临床试验/NCT03004014
NCT03004014已完成不适用

Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy Among Obstructive Sleep Apnea Subjects Referred for Surgical Treatment

Pedro Rodrigues Genta2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2015年1月最近更新:
适应症
干预措施

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

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

No Intervention

OSA subjects referred for surgical treatment will evaluated endoscopically during natural sleep

Propofol Induced Sleep

Other

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

发起方
Pedro Rodrigues Genta
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pedro Rodrigues Genta

Principal Investigator

University of Sao Paulo General Hospital

研究点 (2)

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