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Completed

NCT Number: NCT04907929

Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation

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.

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Key information

Conditions

Cochlear Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Verbal fluency test

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: EPOC

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2021
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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