Sleep Apnea in Lung Cancer: A Prospective Study (SAIL)
Primary Purpose
Lung Cancer, Sleep-Disordered Breathing
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sleep testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring Lung cancer, Sleep apnea, Sleep disordered breathing
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.
Sites / Locations
- Fundacion Jimenez Diaz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sleep testing
Arm Description
Enrolled patients with lung cáncer will undergo home sleep testing during their initial oncologic evaluation, prior to treatment.
Outcomes
Primary Outcome Measures
Prevalence of sleep disordered breathing in lung cancer
Secondary Outcome Measures
Survival of lung cancer in patients with sleep disordered breathing
Lung cancer stage in patients with sleep disordered breathing
Lung cancer progression free survival in patients with sleep disordered breathing
Full Information
NCT ID
NCT02764866
First Posted
May 4, 2016
Last Updated
November 8, 2017
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
1. Study Identification
Unique Protocol Identification Number
NCT02764866
Brief Title
Sleep Apnea in Lung Cancer: A Prospective Study
Acronym
SAIL
Official Title
Prevalence of Sleep Apnea in Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Sleep-Disordered Breathing
Keywords
Lung cancer, Sleep apnea, Sleep disordered breathing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep testing
Arm Type
Experimental
Arm Description
Enrolled patients with lung cáncer will undergo home sleep testing during their initial oncologic evaluation, prior to treatment.
Intervention Type
Other
Intervention Name(s)
Sleep testing
Intervention Description
Home sleep testing
Primary Outcome Measure Information:
Title
Prevalence of sleep disordered breathing in lung cancer
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Survival of lung cancer in patients with sleep disordered breathing
Time Frame
36 months
Title
Lung cancer stage in patients with sleep disordered breathing
Time Frame
12 months
Title
Lung cancer progression free survival in patients with sleep disordered breathing
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis M Seijo, MD, PhD
Organizational Affiliation
Instituto de Investigacion Fundacion Jimenez Diaz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31605903
Citation
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.
Results Reference
derived
Links:
URL
http://www.lungscreen.eu
Description
Lung cancer screening home web page
Learn more about this trial
Sleep Apnea in Lung Cancer: A Prospective Study
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