Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With… (NCT04183348) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss
France79 participantsStarted 2020-07-06
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
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)
Exclusion Criteria:
* Oculomotor disorder
* Bilateral vestibular areflexia
* Neurological and/or psychiatric history
* Person placed under legal protection, guardianship or trusteeship
* Pregnant or nursing woman
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite measure of spatial localization auditory tasks effect of each training protocol on spatial auditory performances