Device for Breathing Frequency Monitoring in Muscular Dystrophy

Not Applicable

Completed

• Conditions: Muscular Dystrophies
• Interventions: Device: RespirHó

• Registration Number: NCT04313595
• Lead Sponsor: IRCCS Eugenio Medea

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-29
• Primary Completion: 2019-07-15
• Study Completion: 2019-07-15
• Study First Submitted: 2020-02-26
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-17
• Last Update Submitted: 2020-03-17
• Study First Posted: 2020-03-18
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breathing frequency monitoring	RespirHó	-

Primary Outcome Measures

Name	Time	Method
Usability of the device (System Usability Scale)	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)	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	After 24 hours of continued use	Recording of any adverse events

Secondary Outcome Measures

Name	Time	Method
Accuracy in measuring the breathing frequency	Immediately after application of the device	Comparison between the measures of respiratory rate by using the device and by using already validated instrumentation: Optoelectronic Plethysmography (OEP), optoelectronic movement analysis system.; Chest wall movements during breathing are simultaneously recorded by the RespirHó device and by Optoelectronic Plethysmography (OEP), in static conditions, and in particular, in supine and seated positions.; OEP allows assessment of ventilatory and breathing pattern by measuring chest-wall movements related to breathing, by using motion capture principles.; Using OEP as reference method it is possible to compare the data recorded with the thoracic and abdominal units of the device RespirHó with those obtained by using OEP for the thoracic and abdominal compartments

Trial Locations

Locations (1)

IRCCS Medea; 🇮🇹 Bosisio Parini, Lecco, Italy