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NCT01179087 Clinical Trial

Sleep Disordered Breathing and Lung Transplantation

Lung Transplantation Clinical Trial

Official title:
Sleep Disordered Breathing and Lung Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01179087
Other study ID # B32220109109
Secondary ID
Status Recruiting
Phase N/A
First received August 9, 2010
Last updated August 5, 2013
Start date August 2010
Est. completion date September 2014

Study information
Verified date August 2013
Source Katholieke Universiteit Leuven
Contact Bertien MA Buyse, MD, PhD
Phone +32 16 34 68 00
Email bertien.buyse@uzleuven.be
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Katholieke Universiteit Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of sleep disordered breathing Polysomnography will be performed at discharge from the hospital (1 month average) 1 month after lung transplantation No
Primary Prevalence of sleep disordered breathing Polysomnographic evaluation 1 year after lung transplantation No
Secondary Pulmonary function Effect of SDB on pulmonary function/BOS 1 year after lung transplantation No
Secondary Investigate possible relationship between SDB and patient medical history 1 year after lung transplantation No
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