NCT02687997

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1.5 years

First QC Date

February 17, 2016

Last Update Submit

September 7, 2017

Conditions

Sleep Apnea Hypopnea SyndromeCOPDEmphysemaLung Cancer

Outcome Measures

Primary Outcomes (1)

  • Prevalence of sleep apnea

    1 year

Study Arms (2)

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

poligraphyOTHER

Sleep study

Diagnostic

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability or unwillingness to undergo a home sleep study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructivePulmonary Disease, Chronic ObstructiveEmphysemaLung Neoplasms

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 23, 2016

Study Start

February 1, 2016

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

ES(1)