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Chewing Efficiency Measured by a Two Colour Chewing Gum Test in Amyotrophic Lateral Sclerosis (ALS) Patients?

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ClinicalTrials.gov Identifier: NCT01772888
Recruitment Status : Recruiting
First Posted : January 21, 2013
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Genton Graf Laurence, University Hospital, Geneva

January 17, 2013
January 21, 2013
May 8, 2018
October 2012
October 2019   (Final data collection date for primary outcome measure)
- Chewing efficiency [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT01772888 on ClinicalTrials.gov Archive Site
  • Lip force [ Time Frame: 5 years ]
  • Bite force [ Time Frame: 5 years ]
  • Calorie and protein intakes [ Time Frame: 5 years ]
  • Saliva volume [ Time Frame: 5 years ]
Same as current
Not Provided
Not Provided
 
Chewing Efficiency Measured by a Two Colour Chewing Gum Test in Amyotrophic Lateral Sclerosis (ALS) Patients?
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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
ALS patients participating in the cohort study of the University Hospital Geneva
Amyotrophic Lateral Sclerosis 11
Not Provided
  • 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.
Schimmel M, Christou P, Herrmann F, Müller F. A two-colour chewing gum test for masticatory efficiency: development of different assessment methods. J Oral Rehabil. 2007 Sep;34(9):671-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
Same as current
October 2019
October 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ALS patients
  • > 18 years
  • Participation in the cohort study

Exclusion Criteria:

  • Refusal of participating in the cohort study
  • Presence of PEG
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Laurence Genton, MD +41223729344
Contact: Claude Pichard, MD PhD
Switzerland
 
 
NCT01772888
12-103
No
Not Provided
Not Provided
Genton Graf Laurence, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Laurence Genton, MD University Hospital, Geneva
University Hospital, Geneva
May 2018