NCT02005679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2017

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

6.5 years

First QC Date

November 22, 2013

Last Update Submit

February 12, 2019

Conditions

Prelingual DeafnessRetention Disorders, Cognitive

Keywords

Prelingual DeafnessRetention Disorders, CognitiveSign languageMini-Mental State

Outcome Measures

Primary Outcomes (1)

  • 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

    At baseline, 1 year and 2 years follow-up visits

Secondary Outcomes (4)

  • Description of MMS-LS test results

    Baseline

  • Diagnostic performance and predictive values of MMS-LS test for acquired dementia.

    Baseline, 1 year and 2 years follow-up visits

  • Correlation between MMS-LS score and CDR level

    Baseline, 1 year and 2 years follow-up visits

  • Diagnostic performance and predictive values of MMS-LS test for suspected dementia.

    Baseline, 1 year and 2 years follow-up visits

Study Arms (1)

deaf persons with potential dementia

EXPERIMENTAL
Behavioral: application of the mini-mental state test

Interventions

application of the mini-mental state testBEHAVIORAL
deaf persons with potential dementia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults\> 18 years
  • Pre-lingual deafness
  • Use of French sign language

You may not qualify if:

  • Refusal to sign the consent
  • Severe visual impairment with lower acuity (less than 0.5)
  • Severe motor difficulties impeding the practice of sign language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital de la Conception, Pôle psychiatrie Centre

Marseille, Bouches-du-Rhône, 13885, France

Location

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, Hauts-de-France, 59962, France

Location

CHU de Rennes, Hôpital de Pontchaillou

Rennes, Ille-et-Vilaine, 35000, France

Location

Unité Régionale d'Accueil et de Soins pour Sourds et malentendants - CHRU Nancy

Nancy, Meurthe-et-Moselle, 54000, France

Location

MeSH Terms

Conditions

DeafnessMemory DisordersSign Language

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsLanguageCommunicationBehaviorManual CommunicationNonverbal Communication

Study Officials

  • Benoît Drion, MD

    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

    STUDY DIRECTOR

  • Amélie Lansiaux, MD

    Groupement des Hôpitaux de l'Institut Catholique de Lille, Medical Research Department

    STUDY CHAIR

  • Isabelle Ridoux, MD

    CHU de Rennes, Hôpital de Pontchaillou

    PRINCIPAL INVESTIGATOR

  • Corine Gilda Scemama-Ammar, MD

    Hôpital de la Conception, Pôle psychiatrie, Marseille

    PRINCIPAL INVESTIGATOR

  • Charlotte Crinquette, MD

    Groupement des Hôpitaux de l'Institut Catholique de Lille

    PRINCIPAL INVESTIGATOR

  • Isabelle Bouillevaux, MD

    CHRU de Nancy, Unité Régionale d'Accueil et de Soins pour Sourds et malentendants

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2013

First Posted

December 9, 2013

Study Start

June 17, 2011

Primary Completion

December 7, 2017

Study Completion

December 7, 2017

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

FR(4)