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Sleep-disordered Breathing After Solid Organ Transplantation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03142022
Enrollment
300
Registered
2017-05-05
Start date
2014-11-30
Completion date
2025-12-31
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplantation, Sleep-disordered Breathing

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.

Interventions

OTHERNo intervention - Diagnostic polysomnography at 1 year after lung transplantation

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients 1 year after lung transplantation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with SDB and type (central or obstructive) of SDB1 year after lung transplantationPrevalence of different types of SDB after lung transplantation

Secondary

MeasureTime frameDescription
Echocardiography1 year after lung transplantationCorrelations between SDB and heart function
Lung function measurement1 year after lung transplantationCorrelations between SDB and lung function
Blood analysis1 year after lung transplantationCorrelations between SDB and renal function
24h blood pressure1 year after lung transplantationEvaluation of relationship between hypertension and SDB

Countries

Belgium

Contacts

Primary ContactDries Testelmans, MD, PhD
dries.testelmans@uzleuven.be00 32 16 34 25 22

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026