Sleep Disordered BreathingNCT01179087
Sleep Disordered Breathing and Lung Transplantation
An observational study of Sleep Disordered Breathing and Lung Transplantation, run by KU Leuven at 1 site in Belgium.
Trial summary
The purpose of the study is to investigate the prevalence, clinical predictors and consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Disordered Breathing, Lung Transplantation
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2010to Sep 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing lung transplantation
Who may be able to join
- Patients with end-stage respiratory failure who are referred for lung transplantation
- Informed consent from patient
Who cannot join
- Patients who are declined for lung transplantation
- Patients < 18 years old
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Katholieke Universiteit Leuven
Leuven, 3000
Bertien Buyse, MD, PhD, +32 16 34 68 00, bertien.buyse@uzleuven.be
Dries Testelmans, MD, PhD, +32 16 34 68 00, dries.testelmans@uzleuven.be
About this study
The purpose of the study is to investigate the prevalence, clinical predictors and consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung transplant recipients.
Read the detailed description
All patients with end-stage respiratory failure who are referred for lung transplantation and are older than 18 years old are enrolled.
We collect:
- Medical history
- Blood pressure
- Anthropometrics
- Pulmonary function
- Arterial blood gas
- Questionnaire (QOL, ESS)
- Sleep diary
- Polysomnography
- Conditions
- Sleep Disordered Breathing, Lung Transplantation
- Keywords
- sleep disordered breathing, lung transplantation
- Medical subject headings
- Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sleep disordered breathing
Polysomnography will be performed at discharge from the hospital (1 month average)
Measured: 1 month after lung transplantation
Prevalence of sleep disordered breathing
Polysomnographic evaluation
Measured: 1 year after lung transplantation
Secondary outcomes (2)
Pulmonary function
Effect of SDB on pulmonary function/BOS
Measured: 1 year after lung transplantation
Investigate possible relationship between SDB and patient medical history
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 posted11 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- More trials run by 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Decramer, KU Leuven
- Investigators
- Bertien MA Buyse, MD, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179087
- Sponsor's protocol ID
- B32220109109
- Status last verified
- Aug 2013
- First submitted
- 9 Aug 2010
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing and Lung Transplantation
- ClinicalTrials.gov ID
- NCT01179087
- Acronym / sponsor ID
- B32220109109
- Conditions
- Sleep Disordered Breathing, Lung Transplantation
- Keywords
- sleep disordered breathing, lung transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 11 Aug 2010 (estimated)
- 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.
The purpose of the study is to investigate the prevalence, clinical predictors and consequences (effect on survival, chronic rejection) of sleep disordered breathing in lung transplant recipients.
Detailed description
All patients with end-stage respiratory failure who are referred for lung transplantation and are older than 18 years old are enrolled.
We collect:
- Medical history
- Blood pressure
- Anthropometrics
- Pulmonary function
- Arterial blood gas
- Questionnaire (QOL, ESS)
- Sleep diary
- Polysomnography
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lung transplantation
Key inclusion criteria (2 listed)
- Patients with end-stage respiratory failure who are referred for lung transplantation
- Informed consent from patient
Key exclusion criteria (2 listed)
- Patients who are declined for lung transplantation
- Patients < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of sleep disordered breathing
Time frame: 1 month after lung transplantation
Polysomnography will be performed at discharge from the hospital (1 month average)
Prevalence of sleep disordered breathing
Time frame: 1 year after lung transplantation
Polysomnographic evaluation
2 secondary outcomes
Pulmonary function
Time frame: 1 year after lung transplantation
Investigate possible relationship between SDB and patient medical history
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 7 Aug 2013.
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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.
Bertien MA Buyse, MD, PhD principal investigator
KU 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 Sleep Disordered Breathing and Lung Transplantation, run by 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 2 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 7 Aug 2013. 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 Bertien MA Buyse, MD, PhD (+32 16 34 68 00, bertien.buyse@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sleep disordered breathing (time frame: 1 month after lung transplantation). The study lists 2 primary outcomes in all. 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 7 Aug 2013.