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Clinical Trials/NCT03142022
NCT03142022
Recruiting
Not Applicable

Sleep-disordered Breathing After Solid Organ Transplantation

Universitaire Ziekenhuizen KU Leuven1 site in 1 country300 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Transplantation
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
300
Locations
1
Primary Endpoint
Number of participants with SDB and type (central or obstructive) of SDB
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Sleep-disordered breathing (SDB) describes a group of disorders in which partial or complete cessation of breathing occurs many times throughout the night, resulting in daytime sleepiness or fatigue that interferes with a person's ability to function and reduces quality of life. Transplantation has become an important treatment modality for end-stage organ failure. Transplant recipients are now living longer and, hence, develop chronic adverse medical conditions. Furthermore, transplantation is associated with weight gain. Despite the high prevalence of poor sleep and cardiovascular conditions among transplant patients, SDB is not well studied in these patients.

Detailed Description

The primary research objective is to evaluate the prevalence, incidence and type (central or obstructive) of SDB in patients after lung transplantation. Secondary research objectives are the evaluation of correlations between severity of SDB and clinical findings (weight, medical therapy, heart function, lung function, renal function, graft failure, ...). Furthermore, the investigators will evaluate the relationship between SDB and cardiovascular morbidity.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
December 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients 1 year after lung transplantation

Exclusion Criteria

  • Refusal of PSG
  • Medical contra-indication to perform PSG

Outcomes

Primary Outcomes

Number of participants with SDB and type (central or obstructive) of SDB

Time Frame: 1 year after lung transplantation

Prevalence of different types of SDB after lung transplantation

Secondary Outcomes

  • Lung function measurement(1 year after lung transplantation)
  • Blood analysis(1 year after lung transplantation)
  • 24h blood pressure(1 year after lung transplantation)
  • Echocardiography(1 year after lung transplantation)

Study Sites (1)

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