跳至主要内容
临床试验/NCT04313595
NCT04313595已完成不适用

A Wearable Device for Breathing Frequency Monitoring: a Pilot Study on Patients With Muscular Dystrophy

IRCCS Eugenio Medea2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年7月29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
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

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)

研究者

发起方
IRCCS Eugenio Medea
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Device for Breathing Frequency Monitoring in... | 临床试验