Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-02-29
2018-07-31
Brief Summary
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Swallowing disorders occur during evolution and involve the prognosis of patients in the short term by the association of dysphagia with severe malnutrition, and aspiration. The issue of phoniatric monitoring is to detect early onset of the swallowing disorders to develop strategies for respiratory protection, food adapted to disturbances, and speech therapy.
The objective of this study is to compare the tongue force in patients with amyotrophic lateral sclerosis at the time of diagnosis and at the onset of swallowing disorders compared to healthy subjects, with the dynamic palatography device developed in the Laboratoire Parole et Langage (UMR 7309, CNRS-Université Aix-Marseille, Aix-en-Provence), which allows the measurement of the strength and duration of the pression of the tongue on the palate.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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healthy volunteers
Constitution of a control group consisting of 20 healthy volunteers, matched for age and sex to establish a "normal" pressure force of the language depending on the age and sex value
medical device
Patients with Amyotrophic Lateral Sclerosis
Constitution of a group of 20 patients with Amyotrophic Lateral Sclerosis (ALS), included at diagnosis of the disease on clinical and electromyographic arguments addressed in speech pathology consultation without a complaint swallowing.
medical device
patients with Amyotrophic Lateral Sclerosis and swallowi
Constitution of a group of 20 patients with Amyotrophic Lateral Sclerosis ( ALS) and swallowing disorders clinically objectified in the ENT consultation.
medical device
Interventions
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medical device
Eligibility Criteria
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Inclusion Criteria
* patients : ALS diagnostic already announced
* healthy subjects : EAT-10 score\<2
Exclusion Criteria
* Presence of risk factor or suspicion of Creutzfeld Jacob Disease
* Allergy/intolerance to the glueing paste
* Antecedent of pathology of the aerodigestive tract
* Other neurologic disease
* Morphologic anomaly of the aerodigestive tract
* Excessive gag reflex
18 Years
ALL
Yes
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Urielle DESALBRES
Role: STUDY_DIRECTOR
Assistance Publique Hôpitaux de Marseille
Locations
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Service ORL Assistance Publique Hôpitaux de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-18
Identifier Type: -
Identifier Source: org_study_id
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