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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04045158
Other study ID # DIAPH-NMD
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 15, 2019
Est. completion date May 10, 2020

Study information

Verified date August 2019
Source Centre d'Investigation Clinique et Technologique 805
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Muscular dystrophies are neurologic disease with higher morbidity and mortality. Cardiac function and respiratory muscles can be affected, in addition with skeletal muscle deficiency . Lung function is classically assessed with functionnal pulmonary tests (FPT) . Ultrasound recently emerged as a non-invasive tool to assess diaphragm function.

The aims of the study are:

- to provide the spectrum of diaphragm ultrasound in patients with muscular dystrophies

- to assess the correlation between diaphragm ultrasound and FPT

- to assess the correlation between diaphragm ultrasound and cardiac function


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date May 10, 2020
Est. primary completion date December 28, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Duchenne muscular dystrophy,

- Becker muscular dystrophy,

- LGMD,

- myotonic dystrophy type 1 and type 2,

- metabolic myopathy,

- mitochondrial myopathy,

- FSHD1 and 2,

- myasthenia

Exclusion Criteria:

- history of cardiac surgery

- history of thoracic surgery

- brain traumatism

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hopital Raymond Poincare Garches

Sponsors (1)

Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary diaphragm ultrasound motion using echography 1 year
Secondary correlation between diaphragm motion (mm) and forced vital capacity(ml) using echography and FPT 1 year
Secondary correlation between diaphragm motion (mm) and inspiratory capacity (ml) using echography and FPT 1 year
Secondary diaphragm thickness (mm) using echography 1 year
Secondary correlation between diaphargm thickness and maximal inspiratory pressure (cmH20) using echography and FPT 1 year
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