NCT01179087

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

4.1 years

First QC Date

August 9, 2010

Last Update Submit

August 5, 2013

Conditions

Sleep Disordered BreathingLung Transplantation

Keywords

sleep disordered breathinglung transplantation

Outcome Measures

Primary Outcomes (2)

  • Prevalence of sleep disordered breathing

    Polysomnography will be performed at discharge from the hospital (1 month average)

    1 month after lung transplantation

  • Prevalence of sleep disordered breathing

    Polysomnographic evaluation

    1 year after lung transplantation

Secondary Outcomes (2)

  • Pulmonary function

    1 year after lung transplantation

  • Investigate possible relationship between SDB and patient medical history

    1 year after lung transplantation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing lung transplantation

You may qualify if:

  • Patients with end-stage respiratory failure who are referred for lung transplantation
  • Informed consent from patient

You may not qualify if:

  • Patients who are declined for lung transplantation
  • Patients \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katholieke Universiteit 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

  • Bertien MA Buyse, MD, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertien MA Buyse, MD, PhD

CONTACT

+32 16 34 68 00bertien.buyse@uzleuven.be

Dries Testelmans, MD, PhD

CONTACT

+32 16 34 68 00dries.testelmans@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 11, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

BE(1)