A Wearable Device for Breathing Frequency Monitoring: a Pilot Study on Patients With Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Usability of the device (System Usability Scale)
研究概览
简要总结
Patients at risk of developing respiratory dysfunctions, such as patients with severe forms of muscular dystrophy, need a careful respiratory assessment, and periodic follow-up visits to monitor the progression of the disease. Continuous monitoring of respiratory activity pattern at home could give additional understandings about disease progression, flanking traditional, intermittent, cardiopulmonary evaluations, allowing prompt clinical intervention, and anticipating respiratory dysfunction. The main objective of the present study is thus to investigate the feasibility of using an innovative wearable device for respiratory monitoring, especially breathing frequency variation assessment, in patients with muscular dystrophy. The comparison between the measurements of breathing frequency obtained by using the IMU-based device and by using the reference method provided optimal results, in terms of accuracy errors, correlation and agreement. Participants positively evaluated the device for what concerns ease of use, comfort, usability and wearability. Moreover, preliminary results confirmed that breathing frequency is an interesting breathing parameter to monitor, at the clinic and at home, because it strongly correlates with the main indexes of respiratory function
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented DMD or LGMD2
- •loss of independent ambulation (wheelchair-bound patients)
- •ability to understand and follow test instructions and to report pain and discomfort.
排除标准
- •presence of metal implants and cardiac pacemakers
- •relevant concomitant comorbidities (e.g.epilepsy)
- •behaviour and/or psychiatric disorders (e.g. emotional problems, anxiety, panic attacks).
结局指标
主要结局
Usability of the device (System Usability Scale)
时间窗: After 24 hours of continued use
System Usability Scale (SUS acceptance and wearability of the device):the scores range from 0 to 100 in 2.5-point increments, with higher values meaning high perceived usability of the system
Acceptability of the device (Technological Acceptance Measure)
时间窗: After 24 hours of continued use
Technological Acceptance Measure (TAM) questionnaire appropriate for the medical device: with higher values meaning high acceptance of the system
Safety of the device
时间窗: After 24 hours of continued use
Recording of any adverse events
次要结局
- Accuracy in measuring the breathing frequency(Immediately after application of the device)
