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

Primary Purpose

Bronchial Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
With and without SDB
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchial Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    With and without SDB

    Arm Description

    comparison of patients with and without sleep-disordered breathing

    Outcomes

    Primary Outcome Measures

    Oxygen desaturation index
    RECORDING BY POLYGRAPHY DEVICE between day 1 and day 15 after enrollment

    Secondary Outcome Measures

    Full Information

    First Posted
    November 27, 2015
    Last Updated
    January 5, 2016
    Sponsor
    University Hospital, Angers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02648087
    Brief Title
    Prevalence of Sleep-disordered Breathing in Patients With a Newly Diagnosed Non Small Cell Lung Cancer
    Acronym
    NEOSAS
    Official Title
    Prevalence of Sleep-disordered Breathing in Patients With a Newly Diagnosed Non Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    November 2018 (Anticipated)
    Study Completion Date
    November 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchial Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    With and without SDB
    Arm Type
    Other
    Arm Description
    comparison of patients with and without sleep-disordered breathing
    Intervention Type
    Device
    Intervention Name(s)
    With and without SDB
    Intervention Description
    Screening of sleep-disordered breathing (SDB)
    Primary Outcome Measure Information:
    Title
    Oxygen desaturation index
    Description
    RECORDING BY POLYGRAPHY DEVICE between day 1 and day 15 after enrollment
    Time Frame
    Between day 1 and day 15

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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