CClinicalTrials.gg
CompletedNCT04907929EPOCUpdated Dec 27, 2024

Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation

An interventional study of targeted speech and cognitive therapy in Cochlear Implants, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cochlear Implants
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Physical and cultural factors that may interfere with testing.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    post-implantation care

    Behavioral: targeted speech and cognitive therapy

Interventions

  • Behavioraltargeted 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

  4. 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.

    Time frame: 3 months

07

Study locations

1 site
  • CHU de Nice
    Nice, 06003, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04907929
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jun 1, 2021
Start date
Dec 15, 2021
Primary completion
Dec 15, 2024
Completion
Dec 15, 2024
Last update
Dec 27, 2024

Study contacts

Nicolas GUEVARA, Dr
study director · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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