Chewing Efficiency Measured by a Two Colour Chewing Gum Test in Amyotrophic Lateral Sclerosis (ALS) Patients?
Amyotrophic Lateral Sclerosis 11
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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?|
- - Chewing efficiency [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Lip force [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Bite force [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Calorie and protein intakes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Saliva volume [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
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.
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 2014. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772888
|Contact: Laurence Genton, MD||+41223729344|
|Contact: Claude Pichard, MD PhD|
|Geneva, Switzerland, 1211|
|Contact: Laurence Genton, MD|
|Principal Investigator: Laurence Genton, MD|
|Sub-Investigator: Valérie Viatte|
|Sub-Investigator: Véronique Karsegard|
|Sub-Investigator: Claude Pichard, MD PhD|
|Sub-Investigator: Dimitrios Samaras, MD|
|Sub-Investigator: Schimmel Martin, MD|
|Sub-Investigator: Frauke Müller, MD|
|Sub-Investigator: Anne-Chantal Héritier, MD|
|Sub-Investigator: Ruxandra Iancu Ferfoglia, MD|
|Sub-Investigator: Jean-Paul Janssens, MD|
|Sub-Investigator: Igor Leuchter, MD|
|Sub-Investigator: Dan Adler, MD|
|Principal Investigator:||Laurence Genton, MD||University Hospital, Geneva|