Text Size

Sleep Disordered Breathing and Lung Transplantation

This study is currently recruiting participants.
Verified August 2012 by Katholieke Universiteit Leuven
Sponsor:
Information provided by (Responsible Party):
Marc Decramer, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01179087
First received: August 9, 2010
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Sleep Disordered Breathing
Lung Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Disordered Breathing and Lung Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Prevalence of sleep disordered breathing [ Time Frame: 1 month after lung transplantation ] [ Designated as safety issue: No ]
    Polysomnography will be performed at discharge from the hospital (1 month average)

  • Prevalence of sleep disordered breathing [ Time Frame: 1 year after lung transplantation ] [ Designated as safety issue: No ]
    Polysomnographic evaluation


Secondary Outcome Measures:
  • Pulmonary function [ Time Frame: 1 year after lung transplantation ] [ Designated as safety issue: No ]
    Effect of SDB on pulmonary function/BOS

  • Investigate possible relationship between SDB and patient medical history [ Time Frame: 1 year after lung transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Marc Decramer, Prof. Dr., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01179087     History of Changes
Other Study ID Numbers: B32220109109
Study First Received: August 9, 2010
Last Updated: August 1, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013