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

Bronchial Cancer Clinical Trial

— NEOSAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02648087
• Other study ID #: 2015 -A00395 - 44
• Status: Not yet recruiting
• Phase: N/A
• First received: November 27, 2015
• Last updated: January 5, 2016
• Start date: January 2016
• Est. completion date: November 2018

Study information

• Verified date: December 2015
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bronchial Cancer
• Carcinoma, Bronchogenic
• Carcinoma, Non-Small-Cell Lung

Intervention

Device:
• With and without SDB
Screening of sleep-disordered breathing (SDB)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen desaturation index	RECORDING BY POLYGRAPHY DEVICE between day 1 and day 15 after enrollment	Between day 1 and day 15	No