EPOC: Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04907929
Collaborator
(none)
20
1
1
16
1.3

Study Details

Study Description

Brief Summary

It has been shown that in deaf people, cortical reorganisation occurs and can accelerate age-related cognitive decline. Therefore, even though a number of Cochlear Implantation Reference Centres are setting up tests to detect cognitive disorders, these remain global and not very specific to deafness. Similarly, auditory rehabilitation could make cognitive decline reversible and bring about major changes in the cognitive functioning of patients which will be decisive for the effectiveness of speech therapy and the effectiveness of implantation. Indeed, it has been shown that, in the deaf postlingual patient, less neuronal activity in the auditory cortex and a reallocation of the cortical regions dedicated to auditory processing to visual tasks took place. This could subsequently influence the outcome of the cochlear implant. The aim of this study is therefore to evaluate the effectiveness of targeted speech therapy aimed at cognitive reorganisation on post-implant gain.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: targeted speech and cognitive therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: post-implantation care

Behavioral: targeted speech and cognitive therapy
One month of targeted speech and cognitive therapy with a speech therapist and with home exercice at home by using a numeric solution

Outcome Measures

Primary Outcome Measures

  1. Verbal fluency test [3 months]

    This test consists of giving as many words as possible beginning with the same letter in two minutes (phonological fluencies) and as many words of the same category in two minutes (semantic fluencies). The interest of the study of fluencies is that they allow us to observe both the preferred functioning of patients (semantic vs. phonological) and other components such as working memory and semantic memory. The duration of this test is four minutes.

  2. Grober et Buschke's test [3 months]

    This test assesses verbal memory and is composed of 16 items belonging to 16 different semantic categories. Indicative recall is used to check the efficiency of encoding and to dissociate memory disorders according to their type.

  3. Door test [3 months]

    This test assesses visual-spatial episodic memory. It consists of presenting 24 pictures of doors to the patient. The patient must then recognise each of these doors in the presence of three distractors. It is divided into two parts which differ in terms of difficulty of recognition.

  4. Hospital Anxiety end Depression scale [3 months]

    The HAD scale is an instrument to screen for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Men or Women ≥ 18 years of age coming for consultation at the implementation centre.

  • Subjects who can read and write French.

  • Patients who are candidates for cochlear implantation and who have not had any contraindication to the operation following the pre-implant assessment.

  • Ability to sign free and informed consent.

  • Subjects with a smartphone or laptop that allows access to the application

Exclusion Criteria:
  • Physical and cultural factors that may interfere with testing.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nice Nice France 06003

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

  • Study Director: Nicolas GUEVARA, Dr, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT04907929
Other Study ID Numbers:
  • 20-AOIP-02
First Posted:
Jun 1, 2021
Last Update Posted:
Jun 1, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 1, 2021