Cochlear Nerve DeafnessEVANCT04183348
Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss
A study testing Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2 and Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2 in people with Cochlear Nerve Deafness and Cochlear Diseases, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
We recently developed a new Neuro-immersion system based on virtual reality and 3D (dimension) motion tracking. This tool makes it possible to evaluate and record the spatial localization performance of sounds and to highlight localization deficits in the three dimensions of space in deaf patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cochlear Nerve Deafness, Cochlear Diseases, Cochlear Hearing Loss
- What is being tested?
- Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2 and Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Jul 2020to 23 May 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all participants (patients and normal hearing adults):
- Ages 18 and 65
- Normal vision (with or without correction)
- Able to understand experimental instructions
- Member of the social security scheme
- Informed of the study and signed the consent form
Show all 13Show fewer
- For hearing standards (NH):
- No hearing problems
- For patients (SU, uIC and bIC):
- Regular follow-up in the ENT (Ear, nose, and throat) department of the Edouard Herriot Hospital in Lyon or the Purpan Hospital, in Toulouse
- Unilateral deep deafness (only for SU patients)
- Holder of one Cochlear implant for more than one year (only for uIC patients)
- Holder of the second Cochlear implant for more than one year (only for bIC patients)
Who cannot join
- Oculomotor disorder
- Bilateral vestibular areflexia
- Neurological and/or psychiatric history
- Person placed under legal protection, guardianship or trusteeship
- Pregnant or nursing woman
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Edouard Herriot
Bron, 69675
Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Purpan, CHU de Toulouse
Toulouse, 31300
About this study
We recently developed a new Neuro-immersion system based on virtual reality and 3D (dimension) motion tracking. This tool makes it possible to evaluate and record the spatial localization performance of sounds and to highlight localization deficits in the three dimensions of space in deaf patients. Unfortunately, there is currently no suitable support to compensate for these localization deficits. However, the discomfort felt by the patients is clearly verbalized.
Thanks to the new virtual reality system, we are now able to develop a training protocol based on spatial sound localization tasks.
- Being tested
- Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2, Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2
- Medical subject headings
- Retrocochlear Diseases, Cochlear Diseases, Hearing Loss, Sensorineural, Hearing Loss, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2Behavioural
During Protocol 1 (visit 1), participants of Group A will perform auditory spatial localization tasks with sensory feedback and during Protocol 2 (visit 2), they will perform auditory tasks without any notion of spatial localization. The 2 visits will be spaced at least 2 weeks (Wash-out).
The effects of each of the protocols on spatial location hearing abilities will be specifically assessed by comparing the results of the different assessments (SPHERE and Visual Discrimination Test) obtained before and after each protocol.
Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2Behavioural
During Protocol 2 (visit 1), participants of Group B will perform auditory tasks without any notion of spatial localization and during Protocol 1 (visit 2), they will perform auditory spatial localization tasks with sensory feedback. The 2 visits will be spaced at least 2 weeks (Wash-out).
The effects of each of the protocols on spatial location hearing abilities will be specifically assessed by comparing the results of the different assessments (SPHERE and Visual Discrimination Test) obtained before and after each protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC) Receives: Behavioral: Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2 |
| Group B | Experimental | 10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC) Receives: Behavioral: Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of spatial localization auditory tasks effect of each training protocol on spatial auditory performances
- Explicit spatial auditory performances ("2d-D") is the combined (head) pointing error, corresponding to the distance in the space between the exact position of the target and the pointing of the subject. In other words, the more precise the subject becomes in his location of a sound source and the lower the value of "2d-D".
- Implicit spatial auditory performances (called "RT") is the response time between the participant's response and the light point.
Measured: 1 day
Secondary outcomes (1)
Measure of the sensory feedback effect on spatial auditory performance by comparing the composite measure of the two training protocols
- Explicit spatial auditory performances ("2d-D") is the combined (head) pointing error, corresponding to the distance in the space between the exact position of the target and the pointing of the subject. In other words, the more precise the subject becomes in his location of a sound source and the lower the value of "2d-D".
- Implicit spatial auditory performances (called "RT") is the response time between the participant's response and the light point
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start6 Jul 2020
- Primary completion23 May 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cochlear Nerve DeafnessStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183348
- Sponsor's protocol ID
- 69HCL19_0567
- Acronym
- EVA
- Status last verified
- Aug 2025
- First submitted
- 27 Nov 2019
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valzolgher C, Bouzaid S, Grenouillet S, Gatel J, Ratenet L, Murenu F, Verdelet G, Salemme R, Gaveau V, Coudert A, Hermann R, Truy E, Farne A, Pavani F. Training spatial hearing in unilateral cochlear implant users through reaching to sounds in virtual reality. Eur Arch Otorhinolaryngol. 2023 Aug;280(8):3661-3672. doi: 10.1007/s00405-023-07886-1. Epub 2023 Mar 11.
PubMed 36905419
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss
- ClinicalTrials.gov ID
- NCT04183348
- Acronym / sponsor ID
- EVA / 69HCL19_0567
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 3 Dec 2019 (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.
We recently developed a new Neuro-immersion system based on virtual reality and 3D (dimension) motion tracking. This tool makes it possible to evaluate and record the spatial localization performance of sounds and to highlight localization deficits in the three dimensions of space in deaf patients. Unfortunately, there is currently no suitable support to compensate for these localization deficits. However, the discomfort felt by the patients is clearly verbalized.
Thanks to the new virtual reality system, we are now able to develop a training protocol based on spatial sound localization tasks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 210 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC) |
| Group B | Experimental | Behavioral: Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 210 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ages 18 and 65
- Normal vision (with or without correction)
- Able to understand experimental instructions
- Member of the social security scheme
- Informed of the study and signed the consent form
Key exclusion criteria (5 listed)
- Oculomotor disorder
- Bilateral vestibular areflexia
- Neurological and/or psychiatric history
- Person placed under legal protection, guardianship or trusteeship
- Pregnant or nursing woman
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 |
|---|---|---|
| Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2During Protocol 1 (visit 1), participants of Group A will perform auditory spatial localization tasks with sensory feedback and during Protocol 2 (visit 2), they will perform auditory tasks without any notion of spatial localization. The 2 visits will be spaced at least 2 weeks (Wash-out). The effects of each of the protocols on spatial location hearing abilities will be specifically assessed by comparing the results of the different assessments (SPHERE and Visual Discrimination Test) obtained before and after each protocol. | Behavioural | Group A |
| Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2During Protocol 2 (visit 1), participants of Group B will perform auditory tasks without any notion of spatial localization and during Protocol 1 (visit 2), they will perform auditory spatial localization tasks with sensory feedback. The 2 visits will be spaced at least 2 weeks (Wash-out). The effects of each of the protocols on spatial location hearing abilities will be specifically assessed by comparing the results of the different assessments (SPHERE and Visual Discrimination Test) obtained before and after each protocol. | Behavioural | Group B |
Primary outcome
Composite measure of spatial localization auditory tasks effect of each training protocol on spatial auditory performances
Time frame: 1 day
* Explicit spatial auditory performances ("2d-D") is the combined (head) pointing error, corresponding to the distance in the space between the exact position of the target and the pointing of the subject. In other words, the more precise the subject becomes in his location of a sound source and the lower the value of "2d-D". * Implicit spatial auditory performances (called "RT") is the response time between the participant's response and the light point.
1 secondary outcome
Measure of the sensory feedback effect on spatial auditory performance by comparing the composite measure of the two training protocols
Time frame: 1 day
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 3 Sep 2025.
- Background: PubMed 36905419Valzolgher C, Bouzaid S, Grenouillet S, Gatel J, Ratenet L, Murenu F, Verdelet G, Salemme R, Gaveau V, Coudert A, Hermann R, Truy E, Farne A, Pavani F. Training spatial hearing in unilateral cochlear implant users through reaching to sounds in virtual reality. Eur Arch Otorhinolaryngol. 2023 Aug;280(8):3661-3672. doi: 10.1007/s00405-023-07886-1. Epub 2023 Mar 11.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2 and Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2 in people with Cochlear Nerve Deafness and Cochlear Diseases, run by Hospices Civils de Lyon at 2 sites 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 13 inclusion and 5 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 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Composite measure of spatial localization auditory tasks effect of each training protocol on spatial auditory performances (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183348, which also lists 1 linked publication.
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 3 Sep 2025.