Amyotrophic Lateral Sclerosis 11 Clinical Trial
Official title:
Chewing Efficiency Measured by a Two Colour Chewing Gum Test: a Marker of Insufficient Nutritional Intakes and Percutaneous Gastrostomy (PEG) Necessity in ALS Patients?
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:
- Maximum bite and lip force decrease.
- Chewing efficiency, maximum bite and lip force decrease more in ALS patients with bulbar
than with spinal onset.
- Chewing efficiency and bite force correlate with energy intakes, nasofibroscopic
assessment, and a validated swallowing questionnaire.
- Saliva volume increases with time and progression of disease and influences masticatory
efficiency.
- Saliva volume is associated with nasofibroscopy assessment.
Methods : Every three months, we will perform:
- As part of the ongoing cohort study (already accepted by the Ethical Committee)
calculation of energy intakes through a 24h recall, nasofibroscopy, swallowing
questionnaire and score of disease severity.
- As part of this study: assessment of dental status at first visit, chewing efficiency
test by a with a colour mixing ability test, maximum voluntary bite and lip force,
saliva volume and calculation of a 3-day dietary recall instead of a 24h recall.
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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