NCT02764866

Brief Summary

The study seeks to determine the prevalence of sleep disordered breathing in a population of patients diagnosed with lung cáncer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable lung-cancer

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
3 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

May 4, 2016

Last Update Submit

November 8, 2017

Conditions

Lung CancerSleep-Disordered Breathing

Keywords

Lung cancerSleep apneaSleep disordered breathing

Outcome Measures

Primary Outcomes (1)

  • Prevalence of sleep disordered breathing in lung cancer

    12 months

Secondary Outcomes (3)

  • Survival of lung cancer in patients with sleep disordered breathing

    36 months

  • Lung cancer stage in patients with sleep disordered breathing

    12 months

  • Lung cancer progression free survival in patients with sleep disordered breathing

    36 months

Study Arms (1)

Sleep testing

EXPERIMENTAL

Enrolled patients with lung cáncer will undergo home sleep testing during their initial oncologic evaluation, prior to treatment.

Other: Sleep testing

Interventions

Sleep testingOTHER

Home sleep testing

Sleep testing

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with recently diagnosed lung cancer, inlcuding all stages of disease.

You may not qualify if:

  • Patients unable to comply with home sleep testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Related Publications (1)

  • Seijo LM, Perez-Warnisher MT, Giraldo-Cadavid LF, Oliveros H, Cabezas E, Troncoso MF, Gomez T, Melchor R, Pinillos EJ, El Hachem A, Gotera C, Rodriguez P, Gonzalez-Mangado N, Peces-Barba G. Obstructive sleep apnea and nocturnal hypoxemia are associated with an increased risk of lung cancer. Sleep Med. 2019 Nov;63:41-45. doi: 10.1016/j.sleep.2019.05.011. Epub 2019 Jun 6.

    PMID: 31605903DERIVED

Related Links

MeSH Terms

Conditions

Lung NeoplasmsSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Luis M Seijo, MD, PhD

    Instituto de Investigacion Fundacion Jimenez Diaz

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 6, 2016

Study Start

February 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations

ES(1)