A Wearable Device for Breathing Frequency Monitoring: a Pilot Study on Patients With Muscular Dystrophy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Muscular Dystrophies
- Sponsor
- IRCCS Eugenio Medea
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Usability of the device (System Usability Scale)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Usability of the device (System Usability Scale)
Time Frame: 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)
Time Frame: 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
Time Frame: After 24 hours of continued use
Recording of any adverse events
Secondary Outcomes
- Accuracy in measuring the breathing frequency(Immediately after application of the device)