Engineering Validation of Leo Device to Assess Clinical Control of Children Recovering From Acute Asthma Exacerbation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ResMed
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- CASI questionnaire
研究概览
简要总结
This is a prospective, observational study to investigate the agreement of the Leo device signal derivation with gold standard asthmatic testing in recently exacerbated asthmatic children.
This study is designed for engineering validation of a wireless, wearable device (Leo) for assessing clinical control of children recovering from acute respiratory event such as asthma attack. The Leo device will monitor chest impedance, ECG and body position to calculate parameters such as respiration rate, heart rate, lung volume, tidal breathing flow and volume curves, and body position. These parameters will then be used to train and algorithm to assess clinical control of asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged ≥2 years old and <18 years old at time of consent
- •Children with a legal guardian able to sign consent for study participation
- •Children and caregivers able to read and understand English or Spanish
- •Children who are currently hospitalized with acute exacerbation of asthma
- •Child's caregiver is able to communicate using SMS
- •Child has an asthma inhaler
排除标准
- •Children with complex medical conditions which may hinder their ability to complete protocol assessments
- •Children with an active skin condition involving the area on the chest wall where the Leo device will be attached. E.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment
- •Children with any implanted medical devices, E.g. cardiac pacemaker
- •Children with any history of known allergic reaction to adhesives or hydrogels, as the ones used with the Leo device
结局指标
主要结局
CASI questionnaire
时间窗: Baseline visit and 7 days post hospital/ED discharge
Questionnaire will be used to determine asthma severity during baseline and follow-up visit. CASI scores include five domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. Range is from 0 -17, with a higher score indicating worse asthma severity
Asthma Flare-up diary
时间窗: Follow-up for 7 days post hospital/ED discharge
Self-reported asthma flare-up diary score will be measured daily during the remote (at home) period in between visits.
Airway resistance through oscillometry test
时间窗: Baseline visit and 7 days post hospital/ED discharge
Asthma severity measures will be determined through oscillometry test at baseline and follow-up visit. Leo measurements will be assessed for agreement with oscillometry measures.
次要结局
- Inhaler usage(Follow-up for 7 days post hospital/ED discharge)
- Tidal breathing from PNT device(7 days post hospital/ED discharge)