Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Association between DISE and physical examination; between DISE and polysomnogram results; between DISE and awake Mueller maneuver; between DISE and lateral cephalometry; and between DISE findings and surgical outcomes
研究概览
简要总结
Prospective, interventional cohort study of drug-induced sleep endoscopy (DISE) to evaluate the upper airway in a cohort of obstructive sleep apnea (OSA) surgical patients. This study has investigated the reliability of this technique, demonstrating moderate-substantial interrater and test-retest reliability. This research has also compared DISE findings to those of the lateral cephalogram X-ray and examined DISE findings in individuals who have not responded to previous sleep apnea surgery. These papers have been published and available through PubMed. Additional research is ongoing, with examination of DISE findings, comparison to other evaluation techniques, and the association between DISE findings and surgical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with OSA considering surgical treatment
排除标准
- •Pregnant women
- •Patients unable to provide informed consent in English themselves
- •Prisoners
- •Allergy to propofol, soybean oil, egg lecithin or glycerol
- •Other contraindication to use of propofol (decision of anesthesiologist or otolaryngologist.)
研究组 & 干预措施
1
OSA Patients considering surgical treatment
干预措施: Propofol sedation (Drug)
结局指标
主要结局
Association between DISE and physical examination; between DISE and polysomnogram results; between DISE and awake Mueller maneuver; between DISE and lateral cephalometry; and between DISE findings and surgical outcomes
时间窗: Preoperative and postoperative
次要结局
未报告次要终点
研究者
Eric J. Kezirian, MD, MPH
Professor, Head and Neck Surgery
University of California, Los Angeles