Bulbar Function in Neuromuscular Patients

Neuromuscular Diseases Clinical Trial

— ORDEG  

Official title:

Prospective Evaluation of Bulbar Function in Neuromuscular Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02097368
• Other study ID #: 2013-A00601-44
• Status: Recruiting
• Phase: N/A
• First received: December 20, 2013
• Last updated: January 24, 2018
• Start date: April 2014
• Est. completion date: December 2020

Study information

• Verified date: January 2018
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: David Orlikowski, MD PhD
• Phone: 33147107777
• Email: david.orlikowski[@]rpc.aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective is prospectively study the upper airways function in an adult population of neuromuscular patients. The main measurement will be the evolution of tongue strength recorded each year during annual clinical evaluation on a 5 years period.

Description:

The main objective is to study the function of the superior airways (tongue and pharynx) in an non invasive way in neuromuscular patients followed in the home ventilation unit of the Raymond POINCARE hospital (myopathy, neuropathy, disease of the neuromuscular junction or anterior horn) or of Necker Hospital and to detect prematurely the bulbar dysfunction.

The secondary objectives of this prospective monocentric observational physiopathological study are:

1. to study the correlation between the possible swallowing dysfunction and the anomalies of the respiratory parameters

2. to establish correlations between infraclinical or clinical and presence of morphological tongue anomalies detected by magnetic resonance imaging like in acid maltase deficiency.

The maximal tongue strength protrusion will be measured according to a method already used in the laboratory to explore sleep apnea syndromes.

Swallowing will be estimated by a non invasive method already used to highlight swallowing disorders in neurological and muscular pathologies This method will be associated with a method of recording of thoracic and abdominal movements.

Data wil be compared to a control database obtained for a previous study

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 70 Years

Eligibility

Inclusion Criteria:

• neuromuscular disorder

• age greater than or equal to 6

• Hospitalization in Home Ventilation Unit - Written informed consent

Exclusion Criteria:

• patient's refusal to participate

• major swallowing disfunction

• Acute respiratory failure

• no affiliation to social security

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Procedure:
• tongue strength measurement
tongue strength measurement
• respiratory function measurement
respiratory function measurement
• swallowing tests
swallowing tests

Other:
• Magnetic resonance imaging
Magnetic resonance imaging

Locations

Country	Name	City	State
France	Home Ventilation Unit, Raymond Poincare Hospital	Garches
France	Non invasive ventilation Unit - Necker Hospital	Paris

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	Change of tongue strength measurement	Measurement using mechanical force transducer	5 years
Secondary	swallowing tests	Non invasive measurement of swallowing function using surface electromyography, accelerometry and inductance plethysmography	5 years
Secondary	Respiratory parameters	Vital capacity and respiratory muscle strength measurement using spirometry and manometry	5 years
Secondary	Vital capacity	Spirometry	5 years
Secondary	Respiratory muscle strength	manometry (maximal inspiratory pressure and expiratory pressure)	5 years