NCT02270853

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

April 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

2.7 years

First QC Date

October 14, 2014

Last Update Submit

February 17, 2016

Conditions

Keywords

ApneaLinkbronchial carcinomasleep apnea screening

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

sleep apnea screening with ApneaLinkTM

OTHER

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

Interventions

ApneaLink is sleep-screening tool that objectively identifies patients with sleep apnea

sleep apnea screening with ApneaLinkTM

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy
  • other already known malignancies or tumors
  • Patients with non-invasive artificial respiration due to a chronic respiratory insufficiencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medizinische Klinik I Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Krankenhaus Merheim

Cologne, North Rhine-Westphalia, 51109, Germany

RECRUITING

Florence-Nightingale Hospital

Düsseldorf, 40489, Germany

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sleep Apnea SyndromesCarcinoma, Bronchogenic

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung Diseases

Study Officials

  • Michael Dreher, Univ.-Prof.

    RWTH Aachen University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 21, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 18, 2016

Record last verified: 2016-02

Locations