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NCT Number: NCT03142022

Sleep-disordered Breathing After Solid Organ Transplantation

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.

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Key information

Conditions

Lung Transplantation Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Sleep-Disordered Breathing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 1 year after lung transplantation

Exclusion criteria

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

Treatment and study plan

No intervention - Diagnostic polysomnography at 1 year after lung transplantation

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Echocardiography

    Time frame: 1 year after lung transplantation

    Correlations between SDB and heart function

  2. Lung function measurement

    Time frame: 1 year after lung transplantation

    Correlations between SDB and lung function

  3. Blood analysis

    Time frame: 1 year after lung transplantation

    Correlations between SDB and renal function

  4. 24h blood pressure

    Time frame: 1 year after lung transplantation

    Evaluation of relationship between hypertension and SDB

Study contacts

Contact information is provided by the study sponsor or research team.

Dries Testelmans, MD, PhD

CONTACT

[email protected]

00 32 16 34 25 22

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
May 5, 2017
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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