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
About this trial
This is an interventional diagnostic trial for Bronchial Cancer
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
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
NCT ID
NCT02648087
First Posted
November 27, 2015
Last Updated
January 5, 2016
Sponsor
University Hospital, Angers
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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