Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation

Cochlear Implants Clinical Trial

— EPOC  

Official title:

Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04907929
• Other study ID #: 20-AOIP-02
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: October 1, 2026

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Nicolas GUEVARA, Dr
• Phone: 4 92 03 17 00
• Email: guevara.n[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Implants

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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