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Sleep Apnea in Lung Cancer: A Prospective Study

Prevalence of Sleep Apnea in Lung Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02764866
Acronym
SAIL
Enrollment
83
Registered
2016-05-06
Start date
2016-02-29
Completion date
2017-11-30
Last updated
2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Sleep-Disordered Breathing

Keywords

Lung cancer, Sleep apnea, Sleep disordered breathing

Brief summary

The study seeks to determine the prevalence of sleep disordered breathing in a population of patients diagnosed with lung cáncer.

Detailed description

Obstructive sleep apnea hypopnea syndrome (OSAHS) is an important medical condition which causes significant morbidity and mortality. The prevalence of OSAHS in Spain is 4-6% in men and 2-4% in women and rises steadily with age. Snoring and smoking have been independently linked, and smoking may be a risk factor for developing OSAHS. This is particularly true of heavy smokers (\> 2 packs/day), those at greatest risk for LC. Associations between OSAHS and some forms of cancer have been described in humans, especially in those experiencing nocturnal hypoxemia, and intermittent hypoxia has been linked to the progression of cancer in animal models. LC is currently the leading cause of cancer deaths in developped nations. A link between OSAHS and LC, therefore, is plausible. Sleep disordered breathing may be common among patients recently diagnosed of lung cancer and may contribute to tumor progression. Objectives: a) To perform home sleep testing in patients recently diagnosed with lung cancer in order to determine the prevalence of sleep disordered breathing in this patient population. b) To include biological samples obtained from all participants, including surgically treated patients with stage I / IIp LC through the program in the CIBERES Pulmonary Biobank Platform. Biological samples will be preserved under different storage conditions for subsequent determination of molecular biomarkers. c) To follow-up lung cancer patients with and without sleep disordered breathing in order to determine the potential influence OSAHS might have on their prognosis. Prospective screening for sleep disordered breathing will be performed by home sleep testing in 100 subjects diagnosed with lung cancer, irrespective of stage at diagnosis, who give their consent. A modified epidemiologic questionnaire for sleep disordered breathing will also be administered. Patients identified as suffering from OSAHS will be referred to sleep clinic. Biologic samples and lung function studies will be obtained in all participating patients. All patients with lung cancer will undergo follow-up for at least three years or until their demise, and those identified with OSAHS will also be followed in sleep clinic. The prevalence of OSAHS in this patient population will be determined. A link between OSAHS, and especially intermittent nocturnal hypoxemia, and tumor progression will be sought.

Interventions

OTHERSleep testing

Home sleep testing

Sponsors

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* All patients with recently diagnosed lung cancer, inlcuding all stages of disease.

Exclusion criteria

* Patients unable to comply with home sleep testing.

Design outcomes

Primary

MeasureTime frame
Prevalence of sleep disordered breathing in lung cancer12 months

Secondary

MeasureTime frame
Survival of lung cancer in patients with sleep disordered breathing36 months
Lung cancer stage in patients with sleep disordered breathing12 months
Lung cancer progression free survival in patients with sleep disordered breathing36 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026