跳至主要内容
临床试验/NCT06232356
NCT06232356招募中不适用

Respiratory Health Screening Using a Mobile Device

SEPAR- EPOC2 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2023年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
275
试验地点
2
主要终点
Main Outcome

研究概览

简要总结

Respiratory diseases are a common cause of mortality and disability at the worldwide and national levels. Many of them are characterized by underdiagnosis and diagnosis in advanced stages of the disease, and in most of them, forced spirometry is one of the fundamental tools to assess the diagnosis and seriousness of the disease.

To help in improving the detection of respiratory diseases and the understanding of the respiratory health of the general population, one possible solution would be to develop a mobile application that could assess respiratory health by using the sound signal of exhaled air recorded by a mobile microphone.

This project will aim to validate a mobile application (WebApp) for the detection of pulmonary function disorders. It is planned to recruit 267 subjects, with and without respiratory disease, who are attended in pulmonary function laboratories of 10 Spanish hospitals, to compare the sensitivity of this application in the diagnosis of pulmonary function disorders (either obstructive patterns or PRISm) versus the gold standard (spirometry). Ease of use and user satisfaction with the application will also be assessed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Adult subjects with age range between 18 and 80 years old
  • Signing the informed consent form
  • Subjects scheduled for respiratory function tests at the pulmonary function laboratory for clinical reasons
  • Having a cell phone and be willing to install the application

排除标准

  • Contraindication to perform any of the protocol procedures
  • Inability to answer the study questionnaires.

结局指标

主要结局

Main Outcome

时间窗: At the time of assessment

Proportion of lung function abnormalities (defined as FEV1/FVC\<0.7 or LLN) detected with the mobile app

次要结局

  • Secondary Outcome(At the time of assessment)

研究者

发起方
SEPAR- EPOC
申办方类型
Other
责任方
Sponsor

研究点 (2)

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