Prevalence of Sleep Disordered Breathing in a Lung Cancer... | NCT02687997

Studies
Prevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort

NCT02687997

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status

Completed

Last Update Posted

Sep 11, 2017Actual

Enrollment

282Actual

Phase

Not Applicable

Conditions

Sleep Apnea Hypopnea Syndrome
COPD
Emphysema
Lung Cancer

Interventions

poligraphy

Countries

Spain

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

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Jul 31, 2017Actual

Completion Date

Jul 31, 2017Actual

First Submitted Date

Feb 17, 2016

First Submission Date that Met QC Criteria

Feb 17, 2016

First Posted Date

Feb 23, 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

Sep 7, 2017

Last Update Posted Date

Sep 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

LUIS SEIJO MACEIRAS, Attending Physician, Instituto de Investigación Sanitaria de la Fundación Jiménez DíazPrincipal Investigator

Lead Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez DíazOTHER

Collaborators

Not provided

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

Prospective study of sleep disordered breathing in a lung cancer screening cohort.

Detailed Description

The proposed study is a prospective single arm study evaluating the prevalence of sleep disordered breathing in a cohort of lung cancer screening patients.

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

282Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic	Experimental	Patients enrolled in lung cancer screening subjected to a sleep study.	Other: poligraphy
Contro	No Intervention	Patients enrolled in lung cancer screening not included in the diagnostic intervention arm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
poligraphy	Other	Sleep study	Diagnostic

Measure	Description	Time Frame
Prevalence of sleep apnea		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 55-75.
> 30 pack years tobacco exposure.
Enrolled in lung cancer screening program.

Exclusion Criteria:

Inability or unwillingness to undergo a home sleep study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundacion Jimenez Diaz		Madrid		28040	Spain

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D029424	Pulmonary Disease, Chronic Obstructive
D004646	Emphysema
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided