Device for Breathing Frequency Monitoring in Muscular Dystrophy

IRCCS Eugenio Medea

Status

Completed

Conditions

Muscular Dystrophies

Treatments

Device: RespirHó

Study type

Interventional

Funder types

Other

Identifiers

NCT04313595

534

Details and patient eligibility

About

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

Enrollment

15 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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).