OSA in Never Smokers With Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05224180
• Other study ID #: 21071691236
• Status: Recruiting
• Start date: November 3, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Jaeyoung Cho, M.D., Ph.D.
• Phone: +82-2-2072-2503
• Email: apricot6[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of obstructive sleep apnea in never smokers with lung cancer	A primary outcome measure in a cross-sectional analysis of a prospective cohort study	1 week
Primary	Effects of obstructive sleep apnea on lung cancer mortality and overall mortality	A primary outcome measure in a longitudinal analysis of prospective cohort study	Follow up for 5 years
Secondary	Association between apnea-hyponea index (AHI) and the stage of lung cancer	A secondary outcome measure in a cross-sectional analysis of a prospective cohort study.	1 week
Secondary	Association between the oxygen desaturation index (ODI) and the stage of lung cancer	A secondary outcome measure in a cross-sectional analysis of a prospective cohort study.	1 week
Secondary	Association between the sleep time spent with oxygen saturation< 90% (TS90) and the stage of lung cancer	A secondary outcome measure in a cross-sectional analysis of a prospective cohort study.	1 week
Secondary	Effect of the apnea-hyponea index (AHI) on lung cancer mortality and overall mortality	A secondary outcome measure in a longitudinal analysis of prospective cohort study.	Follow up for 5 years
Secondary	Effect of the oxygen desaturation index (ODI) on lung cancer mortality and overall mortality	A secondary outcome measure in a longitudinal analysis of prospective cohort study.	Follow up for 5 years
Secondary	Effect of the sleep time spent with oxygen saturation< 90% (TS90) on lung cancer mortality and overall mortality	A secondary outcome measure in a longitudinal analysis of prospective cohort study.	Follow up for 5 years