Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation

NCT04907929 | Completed

• 1 other identifier: 20-AOIP-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cochlear Implants

Outcome Measures

Primary Outcomes (4)

• Verbal fluency test

  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.

  3 months

• Grober et Buschke's test

  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 months

• Door test

  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.

  3 months

• Hospital Anxiety end Depression scale

  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.

  3 months

Study Arms (1)

post-implantation care

EXPERIMENTAL

Behavioral: targeted speech and cognitive therapy

Interventions

targeted speech and cognitive therapy BEHAVIORAL

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

post-implantation care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Physical and cultural factors that may interfere with testing.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nicolas GUEVARA, Dr

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: June 1, 2021
• Study Start: December 15, 2021
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)