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临床试验/NCT05224180
NCT05224180已完成不适用

Obstructive Sleep Apnea in Never Smokers With Newly Diagnosed Lung Cancer: Prevalence and Impact on Prognosis

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2021年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
Effects of obstructive sleep apnea on lung cancer mortality and overall mortality

研究概览

简要总结

Previous studies have yielded inconsistent findings regarding the association between obstructive sleep apnea and the prevalence and mortality of lung cancer. Smoking history, a common risk factor for lung cancer, chronic obstructive pulmonary disease, and obstructive sleep apnea, may act as a confounding variable, limiting interpretation of the results. The aim of this study is to evaluate the prevalence of obstructive sleep apnea in never smokers with lung cancer and to determine the effect of obstructive sleep apnea on the prognosis of lung cancer. Enrolled patients will undergo respiratory polygraphy before beginning treatment for lung cancer. This prospective cohort includes both cross sectional and longitudinal analyses.

研究设计

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

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •- Never smokers who are admitted to the Seoul National University Hospital and newly diagnosed with lung cancer, with ECOG Performance Status 0 or 1

排除标准

  • •Patients who have received treatment for lung cancer before the enrollment
  • •Patients who have received treatment for OSA before the enrollment
  • •Patients with an expected life expectancy of less than 3 months
  • •Patients with neuromuscular disease, chronic opioid medication use, or severe insomnia not controlled by medication
  • •Patients receiving supplemental oxygen therapy due to underlying diseases including heart failure, chronic obstructive pulmonary disease, interstitial pulmonary disease, hypoventilation syndrome, stroke, or whose baseline oxygen saturation is less than 90%
  • •Patients with unstable medical conditions within the preceding 3 months (hospitalization due to acute exacerbation of underlying lung disease, diagnosis of unstable angina or myocardial infarction, history of percutaneous coronary intervention or coronary artery bypass surgery, or diagnosis of transient ischemic attack or stroke)
  • •Patients with an inability or unwillingness to provide informed consent

结局指标

主要结局

Effects of obstructive sleep apnea on lung cancer mortality and overall mortality

时间窗: Follow up for 5 years

A primary outcome measure in a longitudinal analysis of prospective cohort study

Prevalence of obstructive sleep apnea in never smokers with lung cancer

时间窗: 1 week

A primary outcome measure in a cross-sectional analysis of a prospective cohort study

次要结局

  • Association between apnea-hyponea index (AHI) and the stage of lung cancer(1 week)
  • Association between the oxygen desaturation index (ODI) and the stage of lung cancer(1 week)
  • Effect of the oxygen desaturation index (ODI) on lung cancer mortality and overall mortality(Follow up for 5 years)
  • Effect of the apnea-hyponea index (AHI) on lung cancer mortality and overall mortality(Follow up for 5 years)
  • Association between the sleep time spent with oxygen saturation< 90% (TS90) and the stage of lung cancer(1 week)
  • Effect of the sleep time spent with oxygen saturation< 90% (TS90) on lung cancer mortality and overall mortality(Follow up for 5 years)

研究者

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

Jaeyoung Cho

Assistant Professor

Seoul National University Hospital

研究点 (1)

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