Sleep-disordered Breathing After Solid Organ Transplantation

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Transplantation; Sleep-disordered Breathing
• Intervention / Treatment: Other: No intervention - Diagnostic polysomnography at 1 year after lung transplantation

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Dries Testelmans, MD, PhD; Phone Number: 00 32 16 34 25 22; Email: dries.testelmans@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Dries Testelmans, MD, PhD; Phone Number: 00 32 16 342522; Email: dries.testelmans@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients 1 year after lung transplantation are systematically evaluated by polysomnography.

Description

Inclusion Criteria:

• Patients 1 year after lung transplantation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SDB and lung transplantation; Polysomnography at 1 year after lung transplantation.	Other: No intervention - Diagnostic polysomnography at 1 year after lung transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Dries Testelmans, MD, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Respiratory Aspiration
• Other Study ID Numbers: S53746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO