Clinical trial NCT05224180: OSA in Never Smokers With Lung Cancer
Official title: Obstructive Sleep Apnea in Never Smokers With Newly Diagnosed Lung Cancer: Prevalence and Impact on Prognosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Obstructive Sleep Apnea
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients in a tertiary referral hospital

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of obstructive sleep apnea in never smokers with lung cancer
timeFrame: 1 week
measure: Effects of obstructive sleep apnea on lung cancer mortality and overall mortality
timeFrame: Follow up for 5 years
Secondary outcomes:
measure: Association between apnea-hyponea index (AHI) and the stage of lung cancer
timeFrame: 1 week
measure: Association between the oxygen desaturation index (ODI) and the stage of lung cancer
timeFrame: 1 week
measure: Association between the sleep time spent with oxygen saturation< 90% (TS90) and the stage of lung cancer
timeFrame: 1 week
measure: Effect of the apnea-hyponea index (AHI) on lung cancer mortality and overall mortality
timeFrame: Follow up for 5 years
measure: Effect of the oxygen desaturation index (ODI) on lung cancer mortality and overall mortality
timeFrame: Follow up for 5 years
measure: Effect of the sleep time spent with oxygen saturation< 90% (TS90) on lung cancer mortality and overall mortality
timeFrame: Follow up for 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jaeyoung Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: