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NCT02270853 Clinical Trial

SAS in Patients With Bronchial Carcinoma

Sleep Apnea Syndrome Clinical Trial

— SAS CA  

Official title:
Incidence of Sleep Apnea Syndrome (SAS) in Patients With Bronchial Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02270853
Other study ID # 13-136
Secondary ID
Status Recruiting
Phase N/A
First received October 14, 2014
Last updated February 17, 2016
Start date April 2014
Est. completion date December 2016

Study information
Verified date February 2016
Source RWTH Aachen University
Contact Angela Habier
Phone 0492418037429
Email ahabier@ukaachen.de
Is FDA regulated No
Health authority Germany: district government of Cologne, Department 24
Study type Interventional

Clinical Trial Summary

In this study it will be analyzed how often the sleep apnea syndrome can be observed in patients with newly diagnosed lung cancer with the help of ApneaLink device by ResMed.

Description:

Determination of the SAS- frequence in patients with bronchial carcinoma. The patients will be screened at home for 1 night with the ApneaLink device by ResMed. The apneaLink device is a standard screening tool for sleep apnea in clinical practice.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with reasonable suspicion of bronchial carcinoma or histologically proven bronchial carcinoma, which has not been medicated until the study entry and

- Patients with sleep apnea who had recently been diagnosed with bronchial carcinoma.

Exclusion Criteria:

- Pregnancy

- other already known malignancies or tumors

- Patients with non-invasive artificial respiration due to a chronic respiratory insufficiencies

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• sleep apnea screening with ApneaLinkTM
ApneaLink is sleep-screening tool that objectively identifies patients with sleep apnea

Locations
Country Name City State
Germany Medizinische Klinik I Uniklinik RWTH Aachen Aachen NRW
Germany Florence-Nightingale Hospital Düsseldorf
Germany Krankenhaus Merheim Köln NRW

Sponsors (1)
Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary percent of sleep apnea in patients with bronchial carcinoma The percent of sleep apnea in a cohort of patients with bronchial carcinoma will be evaluated. The duration of the study participation is two days. two days No
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