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临床试验/NCT02764866
NCT02764866已完成不适用

Prevalence of Sleep Apnea in Lung Cancer

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
试验地点
2
主要终点
Prevalence of sleep disordered breathing in lung cancer

研究概览

简要总结

The study seeks to determine the prevalence of sleep disordered breathing in a population of patients diagnosed with lung cáncer.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with recently diagnosed lung cancer, inlcuding all stages of disease.

排除标准

  • Patients unable to comply with home sleep testing.

研究组 & 干预措施

Sleep testing

Experimental

Enrolled patients with lung cáncer will undergo home sleep testing during their initial oncologic evaluation, prior to treatment.

干预措施: Sleep testing (Other)

结局指标

主要结局

Prevalence of sleep disordered breathing in lung cancer

时间窗: 12 months

次要结局

  • Survival of lung cancer in patients with sleep disordered breathing(36 months)
  • Lung cancer stage in patients with sleep disordered breathing(12 months)
  • Lung cancer progression free survival in patients with sleep disordered breathing(36 months)

研究者

发起方
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
申办方类型
Other
责任方
Principal Investigator
主要研究者

LUIS SEIJO MACEIRAS

Attending physician

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

研究点 (2)

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