- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05224180
OSA in Never Smokers With Lung Cancer
April 21, 2026 updated by: Jaeyoung Cho, Seoul National University Hospital
Obstructive Sleep Apnea in Never Smokers With Newly Diagnosed Lung Cancer: Prevalence and Impact on Prognosis
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
77
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, South Korea, 03080
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Inpatients in a tertiary referral hospital
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 week
|
|
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
|
Follow up for 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 week
|
|
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.
|
1 week
|
|
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.
|
1 week
|
|
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.
|
Follow up for 5 years
|
|
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.
|
Follow up for 5 years
|
|
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.
|
Follow up for 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jaeyoung Cho, M.D., Ph.D., Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2021
Primary Completion (Actual)
June 24, 2024
Study Completion (Actual)
June 24, 2024
Study Registration Dates
First Submitted
January 10, 2022
First Submitted That Met QC Criteria
January 24, 2022
First Posted (Actual)
February 4, 2022
Study Record Updates
Last Update Posted (Actual)
April 24, 2026
Last Update Submitted That Met QC Criteria
April 21, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21071691236
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
Hospital Felicio RochoNot yet recruitingSleep Apnea/Hypopnea Syndrome | Sleep Apnea Syndrome, Obstructive | Sleep Apnea Syndrome (OSAS) | Sleep Apnea - Obstructive
-
Isabel Moreno HayAmerican Academy of Dental Sleep MedicineRecruitingObstructive Sleep Apnea (SAOS) | Obstructive Sleep Apnea (OSAS)United States
-
Mayo ClinicEnrolling by invitationObstructive Sleep Apnea | OSA | Obstructive Sleep Apnea (OSA)United States
-
Mardin Artuklu UniversityNot yet recruitingObstructive Sleep Apnea | Sleep ApneaTurkey (Türkiye)
-
Yale UniversityNational Heart, Lung, and Blood Institute (NHLBI); ResMed FoundationRecruitingObstructive Sleep Apnea | Sleep ApneaUnited States
-
Hospices Civils de LyonNot yet recruitingObstructive Sleep ApneaFrance
-
University Hospital, AntwerpNot yet recruiting
-
Nyxoah Inc.Not yet recruitingObstructive Sleep ApneaUnited States
-
Restera, Inc.RecruitingObstructive Sleep ApneaAustralia