NCT04313595

Device for Breathing Frequency Monitoring in Muscular Dystrophy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: IRCCS Eugenio Medea · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Muscular Dystrophies

Interventions

Type	Name	Description
DEVICE	RespirHó	The system is a wearable, unobtrusive inertial-sensor-based device for long-term breathing pattern monitoring, also during daily life activities. It consists of three IMU-sensor units (3-axis accelerometer, 3-axis gyroscope, 3-axis magnetometer), positioned respectively on the patient's abdomen and thorax, and on a body area integral with thorax but not affected by espiratory movements. The peripheral units, placed on thorax and abdomen are used to record orientation changes during respiratory movements. The third unit is a central reference unit (hereafter CRU) that receives data from the other two units, save them on an SD card and communicate via Bluetooth with a smartphone / tablet / PC. Moreover, this unit detects only non-respiratory movement, representing not only a pure source of "noise" that must be removed from the thoracic and bdominal signals, but also a pure source of additional information regarding the state of ctivity of the subject .

Timeline

• Start date: 2018-07-29
• Primary completion: 2019-07-15
• Completion: 2019-07-15
• First posted: 2020-03-18
• Last updated: 2020-03-18

Locations

1 site across 1 country: Italy