Sleep-disordered Breathing After Solid Organ Transplantation

Recruiting

• Conditions: Lung Transplantation; Sleep-disordered Breathing
• Interventions: Other: No intervention - Diagnostic polysomnography at 1 year after lung transplantation

• Registration Number: NCT03142022
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients 1 year after lung transplantation

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SDB and lung transplantation	No intervention - Diagnostic polysomnography at 1 year after lung transplantation	Polysomnography at 1 year after lung transplantation.

Primary Outcome Measures

Name	Time	Method
Number of participants with SDB and type (central or obstructive) of SDB	1 year after lung transplantation	Prevalence of different types of SDB after lung transplantation

Secondary Outcome Measures

Name	Time	Method
Lung function measurement	1 year after lung transplantation	Correlations between SDB and lung function
Blood analysis	1 year after lung transplantation	Correlations between SDB and renal function
24h blood pressure	1 year after lung transplantation	Evaluation of relationship between hypertension and SDB
Echocardiography	1 year after lung transplantation	Correlations between SDB and heart function

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium