Sleep-disordered Breathing After Solid Organ Transplantation

NCT ID: NCT03142022

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Lung Transplantation Sleep-disordered Breathing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SDB and lung transplantation

Polysomnography at 1 year after lung transplantation.

No intervention - Diagnostic polysomnography at 1 year after lung transplantation

Intervention Type OTHER

Interventions

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No intervention - Diagnostic polysomnography at 1 year after lung transplantation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients 1 year after lung transplantation

Exclusion Criteria

* Refusal of PSG
* Medical contra-indication to perform PSG
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dries Testelmans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Dries Testelmans, MD, PhD

Role: CONTACT

00 32 16 34 25 22

Facility Contacts

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Dries Testelmans, MD, PhD

Role: primary

00 32 16 342522

Other Identifiers

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S53746

Identifier Type: -

Identifier Source: org_study_id

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