Asthma Lung Sounds With Wearable Stethoscope
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Agreement Between Prototype Wearable Stethoscope and Thinklabs One Digital Stethoscope
研究概览
简要总结
The goal of this clinical trial is to evaluate a prototype wearable stethoscope designed to record lung sounds and assess asthma control in children and adolescents with asthma aged 4 to 17 years who are able to perform spirometry. The study aims to determine whether the prototype wearable stethoscope can accurately detect clinically meaningful changes in lung sounds associated with asthma control and response to bronchodilator treatment.
The main questions it aims to answer are:
- Does the prototype wearable stethoscope demonstrate agreement with recordings obtained from commercially available Thinklabs One Digital Stethoscopes in identifying normal and abnormal lung sounds?
- Are lung sounds detected by the prototype wearable stethoscope associated with asthma symptom control as measured by the Childhood Asthma Control Test (cACT) or Asthma Control Test (ACT)
Researchers will compare recordings obtained from the prototype wearable stethoscope with recordings obtained from FDA-cleared Thinklabs One Digital Stethoscopes to evaluate the prototype device's ability to detect abnormal lung sounds and changes in lung sounds following bronchodilator treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 4 to 17 years
- •Diagnosis of asthma
- •Ability to perform spirometry
- •Assent (as applicable) and parental/legal guardian permission obtained
排除标准
- •Unable to follow spirometry procedures
- •Intubated at the time of enrollment
研究组 & 干预措施
Prototype Wearable Stethoscope Evaluation
Participants aged 4 to 17 years with asthma will complete asthma control questionnaires, undergo pre- and post-bronchodilator spirometry, and have lung sounds recorded simultaneously using a prototype wearable stethoscope and four Thinklabs One Digital Stethoscopes. Lung sound recordings obtained before and after bronchodilator administration will be used to evaluate agreement between devices and assess associations between detected lung sounds, lung function, and asthma control
干预措施: Prototype Wearable Stethoscope (Device)
结局指标
主要结局
Agreement Between Prototype Wearable Stethoscope and Thinklabs One Digital Stethoscope
时间窗: Single study visit (up to 90 minutes).
Agreement between the prototype wearable stethoscope and the FDA-cleared Thinklabs One Digital Stethoscope in the classification of normal versus abnormal lung sounds, assessed using Cohen's Kappa.
Association Between Lung Sounds and Asthma Control Scores
时间窗: Single study visit (up to 90 minutes).
Association between abnormal lung sounds detected by the prototype wearable stethoscope and asthma control as measured by the Childhood Asthma Control Test (cACT) or Asthma Control Test (ACT).
次要结局
- Sensitivity of Abnormal Lung Sound Detection(Single study visit (up to 90 minutes).)
- Specificity of Abnormal Lung Sound Detection(Single study visit (up to 90 minutes).)
- Positive Predictive Value (PPV)(Single study visit (up to 90 minutes).)
- Negative Predictive Value (NPV)(Single study visit (up to 90 minutes).)
研究者
Roberta Kato
Medical Staff/USC Faculty CWR
Children's Hospital Los Angeles