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

September 7, 2017 updated by: LUIS SEIJO MACEIRAS, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Prevalence of Sleep Apnea in a Lung Cancer Screening Cohort Meeting NLST Criteria

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of sleep apnea
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ACTUAL)

July 31, 2017

Study Completion (ACTUAL)

July 31, 2017

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (ESTIMATE)

February 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InsitutoFJD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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