Back to resultsPrevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort (SAILS)
Primary Purpose
Sleep Apnea Hypopnea Syndrome, COPD, Emphysema
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
poligraphy
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea Hypopnea Syndrome
Eligibility Criteria
Inclusion Criteria:
- Age 55-75.
- > 30 pack years tobacco exposure.
- Enrolled in lung cancer screening program.
Exclusion Criteria:
- Inability or unwillingness to undergo a home sleep study.
Sites / Locations
- Fundacion Jimenez Diaz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Diagnostic
Contro
Arm Description
Patients enrolled in lung cancer screening subjected to a sleep study.
Patients enrolled in lung cancer screening not included in the diagnostic intervention arm
Outcomes
Primary Outcome Measures
Prevalence of sleep apnea
Secondary Outcome Measures
Full Information
NCT ID
NCT02687997
First Posted
February 17, 2016
Last Updated
September 7, 2017
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
1. Study Identification
Unique Protocol Identification Number
NCT02687997
Brief Title
Prevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort
Acronym
SAILS
Official Title
Prevalence of Sleep Apnea in a Lung Cancer Screening Cohort Meeting NLST Criteria
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 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
Prospective study of sleep disordered breathing in a lung cancer screening cohort.
Detailed Description
The proposed study is a prospective single arm study evaluating the prevalence of sleep disordered breathing in a cohort of lung cancer screening patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Hypopnea Syndrome, COPD, Emphysema, Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic
Arm Type
Experimental
Arm Description
Patients enrolled in lung cancer screening subjected to a sleep study.
Arm Title
Contro
Arm Type
No Intervention
Arm Description
Patients enrolled in lung cancer screening not included in the diagnostic intervention arm
Intervention Type
Other
Intervention Name(s)
poligraphy
Intervention Description
Sleep study
Primary Outcome Measure Information:
Title
Prevalence of sleep apnea
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 55-75.
> 30 pack years tobacco exposure.
Enrolled in lung cancer screening program.
Exclusion Criteria:
Inability or unwillingness to undergo a home sleep study.
Facility Information:
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Prevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort
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