Sleep Apnea in Lung Cancer: A Prospective Study

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

Detailed Description
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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.

Official Title
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Prevalence of Sleep Apnea in Lung Cancer

Conditions
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Lung Cancer, Sleep-Disordered Breathing

Intervention / Treatment
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* Other: Sleep testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with recently diagnosed lung cancer, inlcuding all stages of disease. Exclusion Criteria: Patients unable to comply with home sleep testing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep testing<br>Enrolled patients with lung cáncer will undergo home sleep testing during their initial oncologic evaluation, prior to treatment. | Other: Sleep testing<br>* Home sleep testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of sleep disordered breathing in lung cancer |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Sleep apnea, Sleep disordered breathing