Device for Breathing Frequency Monitoring in Muscular Dystrophy

NCT04313595 | Completed

• 1 other identifier: 534
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Muscular Dystrophies

Outcome Measures

Primary Outcomes (3)

• Safety of the device

  Recording of any adverse events

  After 24 hours of continued use

• Usability of the device (System Usability Scale)

  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

  After 24 hours of continued use

• Acceptability of the device (Technological Acceptance Measure)

  Technological Acceptance Measure (TAM) questionnaire appropriate for the medical device: with higher values meaning high acceptance of the system

  After 24 hours of continued use

Secondary Outcomes (1)

• Accuracy in measuring the breathing frequency

  Immediately after application of the device

Study Arms (1)

Breathing frequency monitoring

EXPERIMENTAL

Device: RespirHó

Interventions

RespirHó DEVICE

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 .

Breathing frequency monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• documented DMD or LGMD2
• loss of independent ambulation (wheelchair-bound patients)
• ability to understand and follow test instructions and to report pain and discomfort.

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS Medea

Bosisio Parini, Lecco, 23842, Italy

Location

MeSH Terms

Conditions

Muscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 18, 2020
• Study Start: July 29, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)