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临床试验/NCT03142022
NCT03142022招募中不适用

Sleep-disordered Breathing After Solid Organ Transplantation

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Number of participants with SDB and type (central or obstructive) of SDB

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 1 year after lung transplantation

排除标准

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

结局指标

主要结局

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

时间窗: 1 year after lung transplantation

Prevalence of different types of SDB after lung transplantation

次要结局

  • Lung function measurement(1 year after lung transplantation)
  • Blood analysis(1 year after lung transplantation)
  • 24h blood pressure(1 year after lung transplantation)
  • Echocardiography(1 year after lung transplantation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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