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OpenTrials
Completed

NCT Number: NCT05224180

OSA in Never Smokers With Lung Cancer

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Prevalence of obstructive sleep apnea in never smokers with lung cancer

    Time frame: 1 week

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

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

    Time frame: Follow up for 5 years

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

Secondary outcomes

  1. Association between apnea-hyponea index (AHI) and the stage of lung cancer

    Time frame: 1 week

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

  2. Association between the oxygen desaturation index (ODI) and the stage of lung cancer

    Time frame: 1 week

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

  3. Association between the sleep time spent with oxygen saturation< 90% (TS90) and the stage of lung cancer

    Time frame: 1 week

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

  4. Effect of the apnea-hyponea index (AHI) on lung cancer mortality and overall mortality

    Time frame: Follow up for 5 years

    A secondary outcome measure in a longitudinal analysis of prospective cohort study.

  5. Effect of the oxygen desaturation index (ODI) on lung cancer mortality and overall mortality

    Time frame: Follow up for 5 years

    A secondary outcome measure in a longitudinal analysis of prospective cohort study.

  6. Effect of the sleep time spent with oxygen saturation< 90% (TS90) on lung cancer mortality and overall mortality

    Time frame: Follow up for 5 years

    A secondary outcome measure in a longitudinal analysis of prospective cohort study.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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