NCT04313595

Device for Breathing Frequency Monitoring in Muscular Dystrophy

Completed NA Last updated 18 March 2020

What this trial tests

NA trial testing RespirHó in Muscular Dystrophies in 15 participants. Completed in 15 July 2019.

Timeline

29 July 2018

Primary endpoint
15 July 2019

15 July 2019

Quick facts

Lead sponsor	IRCCS Eugenio Medea
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	15
Start date	29 July 2018
Primary completion	15 July 2019
Estimated completion	15 July 2019
Sites	1 location across Italy

Drugs / interventions tested

• RespirHó

Conditions studied

• Muscular Dystrophies — all drugs for Muscular Dystrophies →

Sponsor

IRCCS Eugenio Medea — full company profile →

Who can join

Eligibility, any sex, with Muscular Dystrophies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.