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Study aims: The primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.
Study center: University Hospitals of Geneva Study type: Cohort study with matched controls Study population: 25 ALS patients included in the multidisciplinary cohort study of the University Hospital Geneva between October 2012 and October 2014 and followed for 3 years maximum and 25 controls, matched for age, sex and dental status.
Study duration: Inclusion from October 2012 to October 2016. Follow-up for 3 years.
Study hypothesis: Chewing efficiency, maximum bite and lip force decrease with time in ALS patients and may be a marker of texture adaptation and PEG necessity.
Study aims: The primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.
The secondary aims are to determine, in ALS patients, whether:
Methods : Every three months, we will perform:
Statistics: Evolutions with time and between groups, of chewing efficiency, bite and lip force will be assessed by repeated measures ANOVA. Correlations between two continuous variables will be examined by Spearman's correlation coefficients at the different time points. Correlations between a continuous variable and a binary variable (nasofibroscopic assessment) will be explored by logistic regression with mixed effect model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with ALS | All subjects aged > 18 years, diagnosed with an ALS and included in the multidisciplinary follow-up of the HUG at time of diagnosis will be considered and included, if possible, at their first visit. | ||
| Healthy age and gender-matched subjects | Controls matched for age and gender and dental status and without a medical history for neurological or otolaryngologic disease (1 control for 1 patient). They will be recruited among hospital staff and patients of the dental school. |
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| Measure | Description | Time Frame |
|---|---|---|
| - Chewing efficiency | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Lip force | 5 years | |
| Bite force | 5 years | |
| Calorie and protein intakes |
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Inclusion Criteria:
Exclusion Criteria:
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ALS patients participating in the cohort study of the University Hospital Geneva
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| Name | Affiliation | Role |
|---|---|---|
| Laurence Genton, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17716266 | Background | Schimmel M, Christou P, Herrmann F, Muller F. A two-colour chewing gum test for masticatory efficiency: development of different assessment methods. J Oral Rehabil. 2007 Sep;34(9):671-8. doi: 10.1111/j.1365-2842.2007.01773.x. | |
| 34358835 | Derived | Schimmel M, Leuchter I, Heritier Barras AC, Leles CR, Abou-Ayash S, Viatte V, Esteve F, Janssens JP, Mueller F, Genton L. Oral function in amyotrophic lateral sclerosis patients: A matched case-control study. Clin Nutr. 2021 Aug;40(8):4904-4911. doi: 10.1016/j.clnu.2021.06.022. Epub 2021 Jun 28. |
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| ID | Term |
|---|---|
| C567244 | Amyotrophic Lateral Sclerosis 11 |
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| 5 years |
| Saliva volume | 5 years |