ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort (SAILS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02687997
Recruitment Status : Completed
First Posted : February 23, 2016
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
LUIS SEIJO MACEIRAS, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief Summary:
Prospective study of sleep disordered breathing in a lung cancer screening cohort.

Condition or disease Intervention/treatment Phase
Sleep Apnea Hypopnea Syndrome COPD Emphysema Lung Cancer Other: poligraphy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Sleep Apnea in a Lung Cancer Screening Cohort Meeting NLST Criteria
Study Start Date : February 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic
Patients enrolled in lung cancer screening subjected to a sleep study.
Other: poligraphy
Sleep study

No Intervention: Contro
Patients enrolled in lung cancer screening not included in the diagnostic intervention arm



Primary Outcome Measures :
  1. Prevalence of sleep apnea [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687997


Locations
Spain
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Responsible Party: LUIS SEIJO MACEIRAS, Attending Physician, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT02687997     History of Changes
Other Study ID Numbers: InsitutoFJD
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Lung Neoplasms
Sleep Apnea Syndromes
Emphysema
Sleep Apnea, Obstructive
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes