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临床试验/NCT02977338
NCT02977338Unknown不适用

Evaluation in Patients With Obstructive Sleep Apnea That Had Undergone Diagnosis and Surgical Treatment

Hillel Yaffe Medical Center0 个研究点目标入组 200 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
主要终点
degree of sleep apnea

研究概览

简要总结

Drug induced sleep endoscopy (DISE) is an increasingly performed procedure, offering dynamic upper airway evaluation during artificial sleep before surgical treatment for patients with obstructed sleep apnea (OSA).

DISE is a safe procedure, easily practicable, valid and reliable. The investigators consider it a fundamental clinical procedure that is essential before choosing the surgical treatment. The investigator's results so far suggest that a multilevel collapse is significantly associated with higher apnea hypopnea index values. The investigators think that the weight did not play a significant role in RDI reduction. Results till now show that tailored surgery based on DISE may leverage sleep surgeries outcome significantly, presenting 70% success rate based on the investigator's experience The aim of this study is to evaluate surgery results in patients who underwent DISE prior to their surgery in comparison to their condition prior to the treatment.

详细描述

Drug induced sleep endoscopy (DISE) is an increasingly performed procedure, offering dynamic upper airway evaluation during artificial sleep before surgical treatment for patients with obstructed sleep apnea (OSA).

Aim: To evaluate the value of DISE for tailoring the proper treatment for patients with snoring and OSA.

DISE is a safe procedure, easily practicable, valid and reliable. It is considered a fundamental clinical procedure that is essential before choosing the surgical treatment. Results so far suggest that a multilevel collapse is significantly associated with higher apnea hypopnea index values. The investigators think that the weight did not play a significant role in RDI reduction. Results till now show that tailored surgery based on DISE may leverage sleep surgeries outcome significantly, presenting 70% success rate based on the investigator's experience The aim of this tudy is to evaluate surgery results in patients who underwent DISE prior to their surgery in comparison to their condition prior to the treatment.

The results of the DISE based treatment will be compared with literature data from patients who underwent the surgery without DISE.

Method:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-90
  • Female or Male
  • Fully diagnosed patients with OSA (including sleep laboratory) who are candidates for surgery as a treatment for their condition.

排除标准

  • Patients who are not candidates for surgery as a treatment for their OSA.
  • Patients with high surgical risk.
  • Patients with hematological and oncological background.
  • Pregnancy

结局指标

主要结局

degree of sleep apnea

时间窗: 12 month

Respiratory Disturbance Index (RDI)

时间窗: 12 months

minimum saturation

时间窗: 12 month

degree of snoring

时间窗: 12 month

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

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