ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep Disordered Breathing and Lung Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01179087
Recruitment Status : Unknown
Verified August 2013 by Marc Decramer, Katholieke Universiteit Leuven.
Recruitment status was:  Recruiting
First Posted : August 11, 2010
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Marc Decramer, Katholieke Universiteit Leuven

Brief Summary:
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.

Condition or disease
Sleep Disordered Breathing Lung Transplantation

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
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Disordered Breathing and Lung Transplantation
Study Start Date : August 2010
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Prevalence of sleep disordered breathing [ Time Frame: 1 month after lung transplantation ]
    Polysomnography will be performed at discharge from the hospital (1 month average)

  2. Prevalence of sleep disordered breathing [ Time Frame: 1 year after lung transplantation ]
    Polysomnographic evaluation


Secondary Outcome Measures :
  1. Pulmonary function [ Time Frame: 1 year after lung transplantation ]
    Effect of SDB on pulmonary function/BOS

  2. Investigate possible relationship between SDB and patient medical history [ Time Frame: 1 year after lung transplantation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing lung transplantation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179087


Contacts
Contact: Bertien MA Buyse, MD, PhD +32 16 34 68 00 bertien.buyse@uzleuven.be
Contact: Dries Testelmans, MD, PhD +32 16 34 68 00 dries.testelmans@uzleuven.be

Locations
Belgium
Katholieke Universiteit Leuven Recruiting
Leuven, Belgium, 3000
Contact: Bertien Buyse, MD, PhD    +32 16 34 68 00    bertien.buyse@uzleuven.be   
Contact: Dries Testelmans, MD, PhD    +32 16 34 68 00    dries.testelmans@uzleuven.be   
Principal Investigator: Bertien Buyse, MD, PhD         
Sub-Investigator: Geert Verleden, MD, PhD         
Sub-Investigator: Dries Testelmans, MD, PhD         
Sub-Investigator: Marc Decramer, MD, PhD         
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Bertien MA Buyse, MD, PhD Katholieke Universiteit Leuven

Responsible Party: Marc Decramer, Prof. Dr., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01179087     History of Changes
Other Study ID Numbers: B32220109109
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Keywords provided by Marc Decramer, Katholieke Universiteit Leuven:
sleep disordered breathing
lung transplantation

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes