Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
Study NCT ID:
NCT02097368
Status:
UNKNOWN
Last Update Posted:
2018-01-25
First Post:
2013-12-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bulbar Function in Neuromuscular Patients
Sponsor:
Centre d'Investigation Clinique et Technologique 805
Organization:
Study Overview
Official Title:
Prospective Evaluation of Bulbar Function in Neuromuscular Patients
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORDEG
Brief 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.
Detailed 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: