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SAS in Patients With Bronchial Carcinoma (SAS CA)

Primary Purpose

Sleep Apnea Syndrome, Bronchial Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
sleep apnea screening with ApneaLinkTM
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sleep Apnea Syndrome focused on measuring ApneaLink, bronchial carcinoma, sleep apnea screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Klinik I Uniklinik RWTH AachenRecruiting
  • Krankenhaus MerheimRecruiting
  • Florence-Nightingale HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

sleep apnea screening with ApneaLinkTM

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2014
Last Updated
February 17, 2016
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT02270853
Brief Title
SAS in Patients With Bronchial Carcinoma
Acronym
SAS CA
Official Title
Incidence of Sleep Apnea Syndrome (SAS) in Patients With Bronchial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome, Bronchial Carcinoma
Keywords
ApneaLink, bronchial carcinoma, sleep apnea screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sleep apnea screening with ApneaLinkTM
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
sleep apnea screening with ApneaLinkTM
Intervention Description
ApneaLink is sleep-screening tool that objectively identifies patients with sleep apnea
Primary Outcome Measure Information:
Title
percent of sleep apnea in patients with bronchial carcinoma
Description
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.
Time Frame
two days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Habier
Phone
0492418037429
Email
ahabier@ukaachen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dreher, Univ.-Prof.
Organizational Affiliation
RWTH Aachen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik I Uniklinik RWTH Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Dreher, Univ.-Prof.
Phone
+49 241 80 37127
First Name & Middle Initial & Last Name & Degree
Tobias Müller, PD Dr. med.
Phone
+49 241 80 37127
Facility Name
Krankenhaus Merheim
City
Köln
State/Province
NRW
ZIP/Postal Code
51109
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hendrik Storre, PD.Dr.
Facility Name
Florence-Nightingale Hospital
City
Düsseldorf
ZIP/Postal Code
40489
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krüger Stefan, Prof.
Phone
0211/ 409 3441
Email
stkrueger@kaiserswerther-diakonie.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
29769049
Citation
Dreher M, Kruger S, Schulze-Olden S, Keszei A, Storre JH, Woehrle H, Arzt M, Muller T. Sleep-disordered breathing in patients with newly diagnosed lung cancer. BMC Pulm Med. 2018 May 16;18(1):72. doi: 10.1186/s12890-018-0645-1.
Results Reference
derived

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SAS in Patients With Bronchial Carcinoma

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