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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

Brief Summary:
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.

Condition or disease
Amyotrophic Lateral Sclerosis 11

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 25 participants
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?
Study Start Date : October 2012
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019


Group/Cohort
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.



Primary Outcome Measures :
  1. - Chewing efficiency [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Lip force [ Time Frame: 5 years ]
  2. Bite force [ Time Frame: 5 years ]
  3. Calorie and protein intakes [ Time Frame: 5 years ]
  4. Saliva volume [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ALS patients participating in the cohort study of the University Hospital Geneva
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal of participating in the cohort study
  • Presence of PEG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772888


Contacts
Contact: Laurence Genton, MD +41223729344
Contact: Claude Pichard, MD PhD

Locations
Switzerland
University Hospital Recruiting
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         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Laurence Genton, MD University Hospital, Geneva

Publications:
Responsible Party: Genton Graf Laurence, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01772888     History of Changes
Other Study ID Numbers: 12-103
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Metabolic Diseases
Sclerosis
Pathologic Processes
TDP-43 Proteinopathies
Proteostasis Deficiencies