Sleep Apnea in Lung Cancer: A Prospective Study (SAIL)
Prevalence of Sleep Apnea in Lung Cancer
研究概览
详细说明
Obstructive sleep apnea hypopnea syndrome (OSAHS) is an important medical condition which causes significant morbidity and mortality. The prevalence of OSAHS in Spain is 4-6% in men and 2-4% in women and rises steadily with age. Snoring and smoking have been independently linked, and smoking may be a risk factor for developing OSAHS. This is particularly true of heavy smokers (> 2 packs/day), those at greatest risk for LC. Associations between OSAHS and some forms of cancer have been described in humans, especially in those experiencing nocturnal hypoxemia, and intermittent hypoxia has been linked to the progression of cancer in animal models. LC is currently the leading cause of cancer deaths in developped nations. A link between OSAHS and LC, therefore, is plausible.
Sleep disordered breathing may be common among patients recently diagnosed of lung cancer and may contribute to tumor progression.
Objectives: a) To perform home sleep testing in patients recently diagnosed with lung cancer in order to determine the prevalence of sleep disordered breathing in this patient population. b) To include biological samples obtained from all participants, including surgically treated patients with stage I / IIp LC through the program in the CIBERES Pulmonary Biobank Platform. Biological samples will be preserved under different storage conditions for subsequent determination of molecular biomarkers. c) To follow-up lung cancer patients with and without sleep disordered breathing in order to determine the potential influence OSAHS might have on their prognosis.
Prospective screening for sleep disordered breathing will be performed by home sleep testing in 100 subjects diagnosed with lung cancer, irrespective of stage at diagnosis, who give their consent. A modified epidemiologic questionnaire for sleep disordered breathing will also be administered. Patients identified as suffering from OSAHS will be referred to sleep clinic. Biologic samples and lung function studies will be obtained in all participating patients.
All patients with lung cancer will undergo follow-up for at least three years or until their demise, and those identified with OSAHS will also be followed in sleep clinic. The prevalence of OSAHS in this patient population will be determined. A link between OSAHS, and especially intermittent nocturnal hypoxemia, and tumor progression will be sought.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Madrid、西班牙、28040
- Fundación Jiménez Díaz
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients with recently diagnosed lung cancer, inlcuding all stages of disease.
Exclusion Criteria:
- Patients unable to comply with home sleep testing.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Sleep testing
Enrolled patients with lung cáncer will undergo home sleep testing during their initial oncologic evaluation, prior to treatment.
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Home sleep testing
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Prevalence of sleep disordered breathing in lung cancer
大体时间:12 months
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12 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Survival of lung cancer in patients with sleep disordered breathing
大体时间:36 months
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36 months
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Lung cancer stage in patients with sleep disordered breathing
大体时间:12 months
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12 months
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Lung cancer progression free survival in patients with sleep disordered breathing
大体时间:36 months
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36 months
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合作者和调查者
调查人员
- 首席研究员:Luis M Seijo, MD, PhD、Instituto de Investigacion Fundacion Jimenez Diaz
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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