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RecruitingNCT03142022Updated Jul 3, 2024

Sleep-disordered Breathing After Solid Organ Transplantation

An observational study in Lung Transplantation and Sleep-disordered Breathing, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Transplantation
  • Sleep-disordered Breathing
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's planned enrollment of 300 is above the median of 65 across 184 observational studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • Patients 1 year after lung transplantation

Exclusion criteria

Exclusion Criteria:

  • Refusal of PSG
  • Medical contra-indication to perform PSG
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • SDB and lung transplantation

    Polysomnography at 1 year after lung transplantation.

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

Interventions

  • OtherNo intervention - Diagnostic polysomnography at 1 year after lung transplantation
06

What researchers measure

Primary outcomes

  1. Number of participants with SDB and type (central or obstructive) of SDB

    Prevalence of different types of SDB after lung transplantation

    Time frame: 1 year after lung transplantation

Secondary outcomes

  1. Echocardiography

    Correlations between SDB and heart function

    Time frame: 1 year after lung transplantation

  2. Lung function measurement

    Correlations between SDB and lung function

    Time frame: 1 year after lung transplantation

  3. Blood analysis

    Correlations between SDB and renal function

    Time frame: 1 year after lung transplantation

  4. 24h blood pressure

    Evaluation of relationship between hypertension and SDB

    Time frame: 1 year after lung transplantation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03142022
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
May 5, 2017
Start date
Nov 2014
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jul 3, 2024

Study contacts

Dries Testelmans, MD, PhD
Contact
dries.testelmans@uzleuven.be
00 32 16 34 25 22
Dries Testelmans, MD, PhD
principal investigator · UZ Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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