NCT03142022

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

11.1 years

First QC Date

September 27, 2016

Last Update Submit

July 2, 2024

Conditions

Lung TransplantationSleep-disordered Breathing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Echocardiography

    1 year after lung transplantation

  • Lung function measurement

    1 year after lung transplantation

  • Blood analysis

    1 year after lung transplantation

  • 24h blood pressure

    1 year after lung transplantation

Study Arms (1)

SDB and lung transplantation

Polysomnography at 1 year after lung transplantation.

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

Interventions

No intervention - Diagnostic polysomnography at 1 year after lung transplantationOTHER
SDB and lung transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients 1 year after lung transplantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Dries Testelmans, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dries Testelmans, MD, PhD

CONTACT

00 32 16 34 25 22dries.testelmans@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

May 5, 2017

Study Start

November 1, 2014

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)