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临床试验/NCT03884582
NCT03884582已完成不适用

Observational Study to Detect Cough and Wheeze Sounds Using the CoVa Monitoring System 3

Baxter Healthcare Corporation1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Ability to detect simulated respiratory sounds including coughing and wheezing or identify subjects which have asthma related respiratory issues

研究概览

简要总结

Asthma is a complex and chronic inflammatory disorder which is associated with reversible airway obstruction and bronchial hyperresponsiveness. It is one of the most prevalent chronic diseases in children and prevalence further increases worldwide. Typical symptoms of asthma are breathlessness, cough, wheezing and chest tightness. These symptoms are particularly prevalent at night-time. Understanding and tracking these symptoms can lead to better management of asthma.

Auscultation using a stethoscope is standard clinical practice, however there is currently no available solution to detect respiratory sounds throughout the day and night.

The aim of this study is to investigate the feasibility of detecting respiratory sounds in healthy children with the CoVa patch.

研究设计

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

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participant is between the ages of 4 - 17 years old at the time of consent
  • Participant and/or family member/carer willing to give written consent
  • Participant and/or family member/carer who can read and comprehend english

排除标准

  • Subject believed to be unsuitable for inclusion by the Principle Investigator
  • Subject is pregnant at time of consent
  • Subject is currently enrolled in another medical study

结局指标

主要结局

Ability to detect simulated respiratory sounds including coughing and wheezing or identify subjects which have asthma related respiratory issues

时间窗: 2 Weeks

Subjects will be asked to simulate coughing and wheezing sounds. This data will be analyzed by using a phonocardiogram (microphone) sensor.

次要结局

  • Ability to detect simulated respiratory sounds including wheeze and cough during movement such a simulated situation of moving in bed.(2 Weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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