Sleep Apnea in Lung Cancer: A Prospective Study

NCT ID: NCT02764866

Last Updated: 2017-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-11-30

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.

Conditions

Lung Cancer; Sleep-Disordered Breathing

Keywords

Lung cancer; Sleep apnea; Sleep disordered breathing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sleep testing

Enrolled patients with lung cáncer will undergo home sleep testing during their initial oncologic evaluation, prior to treatment.

Group Type: EXPERIMENTAL

Sleep testing

Intervention Type: OTHER

Home sleep testing

Interventions

Sleep testing

Home sleep testing

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients unable to comply with home sleep testing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

Sponsor Role: lead

Responsible Party

LUIS SEIJO MACEIRAS

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis M Seijo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigacion Fundacion Jimenez Diaz

Locations

Fundacion Jimenez Diaz

Madrid, , Spain

Countries

Spain

References

Seijo LM, Perez-Warnisher MT, Giraldo-Cadavid LF, Oliveros H, Cabezas E, Troncoso MF, Gomez T, Melchor R, Pinillos EJ, El Hachem A, Gotera C, Rodriguez P, Gonzalez-Mangado N, Peces-Barba G. Obstructive sleep apnea and nocturnal hypoxemia are associated with an increased risk of lung cancer. Sleep Med. 2019 Nov;63:41-45. doi: 10.1016/j.sleep.2019.05.011. Epub 2019 Jun 6.

Reference Type: DERIVED

PMID: 31605903 (View on PubMed)

Related Links

http://www.lungscreen.eu

Lung cancer screening home web page

Other Identifiers

InstitutoFJD

Identifier Type: -

Identifier Source: org_study_id