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临床试验/NCT00518128
NCT00518128已完成不适用

Measuring Effectiveness in Sleep Apnea Surgery

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
C-reactive protein level

研究概览

简要总结

The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP.

详细描述

The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP. We propose to measure the impact of surgical OSA treatment on these health-related and functional outcomes measures with the following three analyses: (1) to assess the changes seen with surgical treatment; (2) to compare changes seen with surgical and PAP treatment; and (3) to evaluate the association between changes in respiratory patterns during sleep and changes in health-related and functional outcomes measures for both surgical and PAP treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • 未提供

排除标准

  • Pregnant women
  • Primary snoring or mild OSA (apnea-hypopnea index < 15)
  • Known neurologic, cardiac, hepatic, or renal disorder
  • Acute illness or infection
  • Co-existing sleep disorder other than primary snoring
  • Unable to fast overnight prior to blood draw

结局指标

主要结局

C-reactive protein level

时间窗: Before and after surgery

次要结局

  • Leptin, Homocysteine, Homeostasis model of insulin resistance (HOMA-IR), Heart rate variability, Functional Outcomes of Sleep Questionnaire and Psychomotor Vigilance Task.(Before and after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Kezirian

Associate Professor, Department of Otolaryngology--Head and Neck Surgery

University of California, San Francisco

研究点 (2)

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