Lung CancerNCT05224180
OSA in Never Smokers With Lung Cancer
An observational study of Lung Cancer and Obstructive Sleep Apnea, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Lung Cancer, Obstructive Sleep Apnea
- How many people
- 77 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Nov 2021to 24 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients in a tertiary referral hospital
Who may be able to join
- Never smokers who are admitted to the Seoul National University Hospital and newly diagnosed with lung cancer, with ECOG Performance Status 0 or 1
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lung Cancer, Obstructive Sleep Apnea
- Medical subject headings
- Lung Neoplasms, Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Effects of obstructive sleep apnea on lung cancer mortality and overall mortality
A primary outcome measure in a longitudinal analysis of prospective cohort study
Measured: Follow up for 5 years
Secondary outcomes (6)
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.
Measured: 1 week
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.
Measured: 1 week
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.
Measured: 1 week
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.
Measured: Follow up for 5 years
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.
Measured: Follow up for 5 years
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.
Measured: Follow up for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start3 Nov 2021
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaeyoung Cho, Seoul National University Hospital
- Investigators
- Jaeyoung Cho, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224180
- Sponsor's protocol ID
- 21071691236
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park J, Kim SY, Jo SM, Park YS, Cho J. Obstructive sleep apnea in never-smokers with newly diagnosed lung cancer: a prospective study in a predominantly female Korean population. Sci Rep. 2026 Mar 23;16(1):14579. doi: 10.1038/s41598-026-45232-7.
PubMed 41872397
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea in Never Smokers With Newly Diagnosed Lung Cancer: Prevalence and Impact on Prognosis
- ClinicalTrials.gov ID
- NCT05224180
- Acronym / sponsor ID
- 21071691236
- Conditions
- Lung Cancer, Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients in a tertiary referral hospital
Key inclusion criteria (1 listed)
- Never smokers who are admitted to the Seoul National University Hospital and newly diagnosed with lung cancer, with ECOG Performance Status 0 or 1
Key exclusion criteria (7 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
6 secondary outcomes
Association between apnea-hyponea index (AHI) and the stage of lung cancer
Time frame: 1 week
Association between the oxygen desaturation index (ODI) and the stage of lung cancer
Time frame: 1 week
Association between the sleep time spent with oxygen saturation< 90% (TS90) and the stage of lung cancer
Time frame: 1 week
Effect of the apnea-hyponea index (AHI) on lung cancer mortality and overall mortality
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 41872397Park J, Kim SY, Jo SM, Park YS, Cho J. Obstructive sleep apnea in never-smokers with newly diagnosed lung cancer: a prospective study in a predominantly female Korean population. Sci Rep. 2026 Mar 23;16(1):14579. doi: 10.1038/s41598-026-45232-7.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaeyoung Cho, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Obstructive Sleep Apnea, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of obstructive sleep apnea in never smokers with lung cancer (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05224180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.