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NCT03142022 Clinical Trial

Sleep-disordered Breathing After Solid Organ Transplantation

Lung Transplantation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03142022
Other study ID # S53746
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2014
Est. completion date December 2020

Study information
Verified date December 2019
Source Universitaire Ziekenhuizen Leuven
Contact Dries Testelmans, MD, PhD
Phone 00 32 16 34 25 22
Email dries.testelmans@uzleuven.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients 1 year after lung transplantation

Exclusion Criteria:

- Refusal of PSG

- Medical contra-indication to perform PSG

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention - Diagnostic polysomnography at 1 year after lung transplantation

Locations
Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with SDB and type (central or obstructive) of SDB Prevalence of different types of SDB after lung transplantation 1 year after lung transplantation
Secondary Echocardiography Correlations between SDB and heart function 1 year after lung transplantation
Secondary Lung function measurement Correlations between SDB and lung function 1 year after lung transplantation
Secondary Blood analysis Correlations between SDB and renal function 1 year after lung transplantation
Secondary 24h blood pressure Evaluation of relationship between hypertension and SDB 1 year after lung transplantation
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