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临床试验/NCT05042063
NCT05042063已完成不适用

Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease

Clinica Universidad de Navarra, Universidad de Navarra1 个研究点 分布在 1 个国家目标入组 616 人开始时间: 2021年9月15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
616
试验地点
1
主要终点
Correlation between subjective perception of cough and objective frequency

研究概览

简要总结

This study pretends to evaluate the potential use of Hyfe Cough Tracker (Hyfe) to screen for, diagnose, and support the clinical management of patients with respiratory diseases, while enriching a dataset of disease-specific annotated coughs, for further refinement of similar systems.

详细描述

This is an observational study that will take place in the two campuses of the Clínica Universidad de Navarra, located in Pamplona and Madrid (Spain).

An Artificial-Intelligence system (AI) that detects and records explosive putative cough sounds and identifies human cough based on acoustic characteristics will be used to automatically monitor cough. Potential participants either attending the outpatient clinic or hospitalised with a complaint of cough will be invited by their treating physician, or a member of the research team, and included in the study by part of the research team. A researcher will instruct participants on how to install and use Hyfe Cough Tracker in their smartphones. Participants will be monitored for 30 days (outpatients) or until discharged from the hospital (inpatients). Participants will be asked to complete a daily, online, standardised 100 mm visual analogue scale (VAS) to register changes in the subjective intensity of their cough, while using Hyfe to objectively monitor changes in its frequency.

In parallel, a dataset of annotated cough sounds will be constructed and retrospectively used to assess differences in acoustic patterns of cough, and to evaluate the performance of the system detecting them.

A first subgroup of participants will be recruited outside the clinical setting and asked to provide a series of elicited sounds, including coughs, which will then be used to determine the system's performance accurately discriminating coughs from non-cough sounds, and compared to trained human listeners.

A second subgroup of participants will be will be instructed to use Hyfe, and the related Hyfe Air wearable device continuously for a period between 6 and 24 hours, while they record themselves using a MP3 recorder connected to a lapel microphone. This group will be used to evaluate the performance of Hyfe and Hyfe Air in a real-life setting, with spontaneous coughs.

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
5 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For participants in the main study group
  • Outpatient or inpatients at the Clinical Universidad de Navarra with a complaint of cough.
  • The patient or his/her legal representative, have given consent to participate in the study.
  • For participants in the sub-study groups:
  • Being 18 years or older.
  • Providing consent for the sub-study

排除标准

  • Inability to accept the privacy policy and terms of use of Hyfe.
  • Lack of access to a Wi-Fi network at the site of residence (for the main study group).
  • Unwillingness to regularly use the cough-surveillance system throughout the monitoring period

结局指标

主要结局

Correlation between subjective perception of cough and objective frequency

时间窗: 6 months.

The daily VAS score of participants will be compared to the cough frequency registered by the cough surveillance system. These data will be used to fit a linear regression model to compare self-reported VAS scores to daily cough frequency and calculate a correlation coefficient (r).

次要结局

  • Construction of an annotated cough dataset(5 years.)
  • Sensitivity of the system differentiating coughs caused by different conditions(5 years.)
  • Sensitivity of the system discriminating coughs(6 months.)
  • Negative predictive value (NPV) of the system discriminating coughs(6 months.)
  • Specificity of the system differentiating coughs caused by different conditions(5 years.)
  • Specificity of the system discriminating coughs(6 months.)
  • Positive predictive value (PPV) of the system discriminating coughs(6 months.)

研究者

发起方
Clinica Universidad de Navarra, Universidad de Navarra
申办方类型
Other
责任方
Sponsor

研究点 (1)

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