Prevalence of Sleep-disordered Breathing in Patients With a Newly Diagnosed Non Small Cell Lung Cancer (NEOSAS)

January 5, 2016 updated by: University Hospital, Angers

There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.

The aim of the study is to evaluate this possibility with the help of a night record of sleep and quality of life questionnaires.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.

Enrollment 1200 patients This wide sample is expected to respond to the main and secondary objectives of the study

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with NSCLC undergoing diagnostic
  • Performance status 0,1,2

Exclusion Criteria:

  • >75 years
  • OSA known and in the last 12 months treated PS >2
  • Patients under a long-term oxygen therapy
  • persons deprived of liberty by judicial decision.
  • <18 years

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: With and without SDB
comparison of patients with and without sleep-disordered breathing
Device: With and without SDB
Screening of sleep-disordered breathing (SDB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen desaturation index
Time Frame: Between day 1 and day 15
RECORDING BY POLYGRAPHY DEVICE between day 1 and day 15 after enrollment
Between day 1 and day 15

Collaborators and Investigators

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

Sponsor

University Hospital, Angers

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

January 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015 -A00395 - 44

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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