Mini-Mental State (MMS-LS) and Sign Language (MMS-LS)
Primary Purpose
Prelingual Deafness, Retention Disorders, Cognitive
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
application of the mini-mental state test
Sponsored by
About this trial
This is an interventional diagnostic trial for Prelingual Deafness focused on measuring Prelingual Deafness, Retention Disorders, Cognitive, Sign language, Mini-Mental State
Eligibility Criteria
Inclusion Criteria:
- Adults> 18 years
- Pre-lingual deafness
- Use of French sign language
Exclusion Criteria:
- Refusal to sign the consent
- Severe visual impairment with lower acuity (less than 0.5)
- Severe motor difficulties impeding the practice of sign language
Sites / Locations
- Hôpital de la Conception, Pôle psychiatrie Centre
- CHU de Rennes, Hôpital de Pontchaillou
- Unité Régionale d'Accueil et de Soins pour Sourds et malentendants - CHRU Nancy
- Groupement des Hôpitaux de l'Institut Catholique de Lille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
deaf persons with potential dementia
Arm Description
Outcomes
Primary Outcome Measures
Assessment of internal consistency of MMS-LS test for the diagnosis of cognitive impairment among deaf patients by a correlation analysis followed by Cronbach's alpha test
Secondary Outcome Measures
Description of MMS-LS test results
Explanatory Factors are: age, education level, characteristics of the sign language(fluency level, learning age, usage frequency, usage by other family members)
Diagnostic performance and predictive values of MMS-LS test for acquired dementia.
Sensitivity, specificity, positive and negative predictive values.
Correlation between MMS-LS score and CDR level
We also check that patients having a suspicious CDR (0.5) have a superior MMS-LS score compared to patients having a CDR ≥ 1.
Diagnostic performance and predictive values of MMS-LS test for suspected dementia.
Sensitivity, specificity, positive and negative predictive values
Full Information
NCT ID
NCT02005679
First Posted
November 22, 2013
Last Updated
February 12, 2019
Sponsor
Lille Catholic University
1. Study Identification
Unique Protocol Identification Number
NCT02005679
Brief Title
Mini-Mental State (MMS-LS) and Sign Language
Acronym
MMS-LS
Official Title
Transposition of the Mini-Mental State in Sign Language
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 17, 2011 (Actual)
Primary Completion Date
December 7, 2017 (Actual)
Study Completion Date
December 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In France the prevalence of pre-lingual deafness is between 1 and 1.4 per 1000 habitants, and according to very conservative estimates, about 44 000 deaf persons use the sign language. Additionally, the prevalence of dementia in France is close to 1% (850 000 dements for a total population of 65 millions). The prevalence of dementia in pre-lingual deaf adults has also been described and is between 1 and 1.4 /100 000 habitants.
The Mini Mental State Examination (MMSE) of Folstein is a test recommended to perform the cognitive evaluation for the detection of mental disorders including dementia, and a consensual French version exists prepared by GRECO (Group of Research and Cognitive Assessments). However, to date, there are no simple, rapid and validated screening tests to study cognitive disorders in deaf persons who use the sign language. The only tests available allow a late diagnosis avoiding an optimal treatment of the patients.
Detailed Description
The objective of this study is to assess the intrinsic quality of the tool MMS-LS, a mini-mental state examination that has been adapted to the sign language in order to monitor cognitive disorders in deaf people who speak sign language.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prelingual Deafness, Retention Disorders, Cognitive
Keywords
Prelingual Deafness, Retention Disorders, Cognitive, Sign language, Mini-Mental State
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
deaf persons with potential dementia
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
application of the mini-mental state test
Primary Outcome Measure Information:
Title
Assessment of internal consistency of MMS-LS test for the diagnosis of cognitive impairment among deaf patients by a correlation analysis followed by Cronbach's alpha test
Time Frame
At baseline, 1 year and 2 years follow-up visits
Secondary Outcome Measure Information:
Title
Description of MMS-LS test results
Description
Explanatory Factors are: age, education level, characteristics of the sign language(fluency level, learning age, usage frequency, usage by other family members)
Time Frame
Baseline
Title
Diagnostic performance and predictive values of MMS-LS test for acquired dementia.
Description
Sensitivity, specificity, positive and negative predictive values.
Time Frame
Baseline, 1 year and 2 years follow-up visits
Title
Correlation between MMS-LS score and CDR level
Description
We also check that patients having a suspicious CDR (0.5) have a superior MMS-LS score compared to patients having a CDR ≥ 1.
Time Frame
Baseline, 1 year and 2 years follow-up visits
Title
Diagnostic performance and predictive values of MMS-LS test for suspected dementia.
Description
Sensitivity, specificity, positive and negative predictive values
Time Frame
Baseline, 1 year and 2 years follow-up visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults> 18 years
Pre-lingual deafness
Use of French sign language
Exclusion Criteria:
Refusal to sign the consent
Severe visual impairment with lower acuity (less than 0.5)
Severe motor difficulties impeding the practice of sign language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît Drion, MD
Organizational Affiliation
Groupement des Hôpitaux de l'Institut Catholique de Lille, Unité d'Accueil et de Soins des Sourds en Langue des Signes et Réseau Sourds et Santé
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amélie Lansiaux, MD
Organizational Affiliation
Groupement des Hôpitaux de l'Institut Catholique de Lille, Medical Research Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Isabelle Ridoux, MD
Organizational Affiliation
CHU de Rennes, Hôpital de Pontchaillou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Corine Gilda Scemama-Ammar, MD
Organizational Affiliation
Hôpital de la Conception, Pôle psychiatrie, Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charlotte Crinquette, MD
Organizational Affiliation
Groupement des Hôpitaux de l'Institut Catholique de Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabelle Bouillevaux, MD
Organizational Affiliation
CHRU de Nancy, Unité Régionale d'Accueil et de Soins pour Sourds et malentendants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Conception, Pôle psychiatrie Centre
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13885
Country
France
Facility Name
CHU de Rennes, Hôpital de Pontchaillou
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35000
Country
France
Facility Name
Unité Régionale d'Accueil et de Soins pour Sourds et malentendants - CHRU Nancy
City
Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54000
Country
France
Facility Name
Groupement des Hôpitaux de l'Institut Catholique de Lille
City
Lille
State/Province
Nord Pas De Calais
ZIP/Postal Code
59962
Country
France
12. IPD Sharing Statement
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