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临床试验/NCT04800341
NCT04800341已完成不适用

Collection of Medical Events Occurring During Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2021年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
233
试验地点
1
主要终点
Prevalence of cardiovascular events

研究概览

简要总结

The European database ESADA, containing data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome, prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective is to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

详细描述

The European database ESADA prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation. A partnership agreement exists between University Hospital Grenoble (CHUGA) and ESADA for the reuse of CHUGA data. The data collected at CHUGA as part of the ESADA-Follow-up and outcomes questionnaire are also collected in the other European centers and will be centralized at the level of the coordinating center.

ESADA currently contains data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome. One of the main limitations of this cohort is the relatively limited amount of information concerning the long-term follow-up of the patients included in the registry.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective at the end of this data collection is to aggregate the follow-up data of more than 10,000 patients from all participating European centers to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • already included in the ESADA European database

排除标准

  • refusal to participate

结局指标

主要结局

Prevalence of cardiovascular events

时间窗: up to 15 years

Prevalence of cardiovascular events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of incident cancers

时间窗: up to 15 years

Prevalence of incident cancers during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of deaths

时间窗: up to 15 years

Prevalence of deaths during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of metabolic events

时间窗: up to 15 years

Prevalence of metabolic events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

次要结局

  • Effect of CPAP treatment on the cardiovascular events occurrence(during 6 months)
  • Effect of CPAP treatment on the incident cancers occurrence(during 6 months)
  • Effect of CPAP treatment on the metabolic events occurrence(during 6 months)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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