Lung TransplantationNCT03142022
Sleep-disordered Breathing After Solid Organ Transplantation
An observational study of Lung Transplantation and Sleep-disordered Breathing, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation, Sleep-disordered Breathing
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 1 year after lung transplantation are systematically evaluated by polysomnography.
Who may be able to join
- Patients 1 year after lung transplantation
Who cannot join
- Refusal of PSG
- Medical contra-indication to perform PSG
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Dries Testelmans, MD, PhD, 00 32 16 342522, dries.testelmans@uzleuven.be
About this study
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.
- Conditions
- Lung Transplantation, Sleep-disordered Breathing
- Being tested
- No intervention - Diagnostic polysomnography at 1 year after lung transplantation
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - Diagnostic polysomnography at 1 year after lung transplantationOther
| Study group | Role | What they receive |
|---|---|---|
| SDB and lung transplantation | Polysomnography at 1 year after lung transplantation. Receives: Other: No intervention - Diagnostic polysomnography at 1 year after lung transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with SDB and type (central or obstructive) of SDB
Prevalence of different types of SDB after lung transplantation
Measured: 1 year after lung transplantation
Secondary outcomes (4)
Echocardiography
Correlations between SDB and heart function
Measured: 1 year after lung transplantation
Lung function measurement
Correlations between SDB and lung function
Measured: 1 year after lung transplantation
Blood analysis
Correlations between SDB and renal function
Measured: 1 year after lung transplantation
24h blood pressure
Evaluation of relationship between hypertension and SDB
Measured: 1 year after lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study startNov 2014
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dries Testelmans, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142022
- Sponsor's protocol ID
- S53746
- Status last verified
- Jul 2024
- First submitted
- 27 Sep 2016
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep-disordered Breathing After Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT03142022
- Acronym / sponsor ID
- S53746
- Conditions
- Lung Transplantation, Sleep-disordered Breathing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SDB and lung transplantation | – | Other: No intervention - Diagnostic polysomnography at 1 year after lung transplantationPolysomnography at 1 year after lung transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 1 year after lung transplantation are systematically evaluated by polysomnography.
Key inclusion criteria (1 listed)
- Patients 1 year after lung transplantation
Key exclusion criteria (2 listed)
- Refusal of PSG
- Medical contra-indication to perform PSG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - Diagnostic polysomnography at 1 year after lung transplantation | Other | SDB and lung transplantation |
Primary outcome
Number of participants with SDB and type (central or obstructive) of SDB
Time frame: 1 year after lung transplantation
Prevalence of different types of SDB after lung transplantation
4 secondary outcomes
Echocardiography
Time frame: 1 year after lung transplantation
Lung function measurement
Time frame: 1 year after lung transplantation
Blood analysis
Time frame: 1 year after lung transplantation
24h blood pressure
Time frame: 1 year after lung transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dries Testelmans, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation and Sleep-disordered Breathing, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dries Testelmans, MD, PhD (00 32 16 34 25 22, dries.testelmans@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with SDB and type (central or obstructive) of SDB (time frame: 1 year after lung transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.