NCT02648087

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 6, 2016

Status Verified

December 1, 2015

Enrollment Period

2.8 years

First QC Date

November 27, 2015

Last Update Submit

January 5, 2016

Conditions

Bronchial Cancer

Outcome Measures

Primary Outcomes (1)

  • Oxygen desaturation index

    RECORDING BY POLYGRAPHY DEVICE between day 1 and day 15 after enrollment

    Between day 1 and day 15

Study Arms (1)

With and without SDB

OTHER

comparison of patients with and without sleep-disordered breathing

Device: With and without SDB

Interventions

With and without SDBDEVICE

Screening of sleep-disordered breathing (SDB)

With and without SDB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Bronchogenic

Condition Hierarchy (Ancestors)

Bronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2015

First Posted

January 6, 2016

Study Start

January 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 6, 2016

Record last verified: 2015-12