Cochlear ImplantsEPOCNCT04907929
Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation
A study testing targeted speech and cognitive therapy in people with Cochlear Implants, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implants
- What is being tested?
- targeted speech and cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2021to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Physical and cultural factors that may interfere with testing.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- targeted speech and cognitive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
targeted speech and cognitive therapyBehavioural
One month of targeted speech and cognitive therapy with a speech therapist and with home exercice at home by using a numeric solution
| Study group | Role | What they receive |
|---|---|---|
| post-implantation care | Experimental | Not described Receives: Behavioral: targeted speech and cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start15 Dec 2021
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas GUEVARA, Dr, Study director, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907929
- Sponsor's protocol ID
- 20-AOIP-02
- Acronym
- EPOC
- Status last verified
- Dec 2024
- First submitted
- 28 Apr 2021
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation
- ClinicalTrials.gov ID
- NCT04907929
- Acronym / sponsor ID
- EPOC / 20-AOIP-02
- Conditions
- Cochlear Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post-implantation care | Experimental | Behavioral: targeted speech and cognitive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Physical and cultural factors that may interfere with testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| targeted speech and cognitive therapyOne month of targeted speech and cognitive therapy with a speech therapist and with home exercice at home by using a numeric solution | Behavioural | post-implantation care |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implants
Recruiting
Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
Cochlear Implant Users
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas GUEVARA, Dr study director
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing targeted speech and cognitive therapy in people with Cochlear Implants, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal fluency test (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.