Prevalence of Sleep-disordered Breathing in Patients With... | NCT02648087

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

NCT02648087

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Jan 6, 2016Estimated

Enrollment

1,200Estimated

Phase

Not Applicable

Conditions

Bronchial Cancer

Interventions

With and without SDB

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Nov 2018Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

Nov 27, 2015

First Submission Date that Met QC Criteria

Jan 5, 2016

First Posted Date

Jan 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2016

Last Update Posted Date

Jan 6, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With and without SDB	Other	comparison of patients with and without sleep-disordered breathing	Device: With and without SDB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
With and without SDB	Device	Screening of sleep-disordered breathing (SDB)	With and without SDB

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41812988	Derived	Justeau G, Greillier L, Vinas F, Falchero L, Bylicki O, Bernardi M, Martin F, Simon I, Debieuvre D, Locher C, Bizieux-Thaminy A, Levrat V, Fry S, Guguen C, Goutorbe F, Masson P, Soyez F, Chouaid C, Saulnier P, Gagnadoux F. Association of Sleep-Related Hypoxemia With Survival in Patients With Non-Small Cell Lung Cancer: The NEOSAS Groupe Francais de Pneumo-Cancerologie Study Group. Chest. 2026 Mar 9:S0012-3692(26)00279-5. doi: 10.1016/j.chest.2025.12.060. Online ahead of print.

ID	Term
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms