SAS in Patients With Bronchial Carcinoma (SAS CA)

February 17, 2016 updated by: RWTH Aachen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • Recruiting
        • Medizinische Klinik I Uniklinik RWTH Aachen
        • Contact:
          • Michael Dreher, Univ.-Prof.
          • Phone Number: +49 241 80 37127
        • Contact:
          • Tobias Müller, PD Dr. med.
          • Phone Number: +49 241 80 37127
      • Köln, NRW, Germany, 51109
        • Recruiting
        • Krankenhaus Merheim
        • Contact:
          • Hendrik Storre, PD.Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: sleep apnea screening with ApneaLinkTM
This is the only group in the present study. Patients with bronchial carcinoma (or reasonable suspicion) perform sleep screening with ApneaLinkTM at home or during the hospitalization.
Device: sleep apnea screening with ApneaLinkTM
ApneaLink is sleep-screening tool that objectively identifies patients with sleep apnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percent of sleep apnea in patients with bronchial carcinoma
Time Frame: two days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Michael Dreher, Univ.-Prof., RWTH Aachen University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

October 14, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (ESTIMATE)

October 21, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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