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Clinical Trials/NCT04313595
NCT04313595
Completed
N/A

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

IRCCS Eugenio Medea1 site in 1 country15 target enrollmentJuly 29, 2018

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

Registry
clinicaltrials.gov
Start Date
July 29, 2018
End Date
July 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
IRCCS Eugenio Medea
Responsible Party
Sponsor

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)

Study Sites (1)

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