Sleep Disordered Breathing and Lung Transplantation

August 5, 2013 updated by: Marc Decramer, KU Leuven
The purpose of the study is to investigate the prevalence, clinical predictors and consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung transplant recipients.

Study Overview

Status

Unknown

Conditions

Detailed Description

All patients with end-stage respiratory failure who are referred for lung transplantation and are older than 18 years old are enrolled.

We collect:

  • Medical history
  • Blood pressure
  • Anthropometrics
  • Pulmonary function
  • Arterial blood gas
  • Questionnaire (QOL, ESS)
  • Sleep diary
  • Polysomnography

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Katholieke Universiteit Leuven
        • Sub-Investigator:
          • Dries Testelmans, MD, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bertien Buyse, MD, PhD
        • Sub-Investigator:
          • Geert Verleden, MD, PhD
        • Sub-Investigator:
          • Marc Decramer, MD, PhD

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing lung transplantation

Description

Inclusion Criteria:

  • Patients with end-stage respiratory failure who are referred for lung transplantation
  • Informed consent from patient

Exclusion Criteria:

  • Patients who are declined for lung transplantation
  • Patients < 18 years old

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of sleep disordered breathing
Time Frame: 1 month after lung transplantation
Polysomnography will be performed at discharge from the hospital (1 month average)
1 month after lung transplantation
Prevalence of sleep disordered breathing
Time Frame: 1 year after lung transplantation
Polysomnographic evaluation
1 year after lung transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function
Time Frame: 1 year after lung transplantation
Effect of SDB on pulmonary function/BOS
1 year after lung transplantation
Investigate possible relationship between SDB and patient medical history
Time Frame: 1 year after lung transplantation
1 year after lung transplantation

Collaborators and Investigators

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

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Bertien MA Buyse, MD, PhD, KU Leuven

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

August 1, 2010

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (Estimate)

August 11, 2010

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 5, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B32220109109

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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