Cochlear Prosthesis Implantation Clinical Trial
— MICLOOfficial title:
Impact of Microphone Positioning on Auditory Performance in Cochlear Implant Users
The construction of our auditory space requires several prerequisites, including localization abilities in 3D (azimuth, elevation and distance). These abilities rely on the proper development and functionality of the auditory system to extract various acoustic cues from our environment. Extraction and analysis of these auditory cues are based on the synchronous use of ears, called binaurality. Other natural behaviours are useful to precisely determine the location of a sound source: visual information and head movements. The slightest anatomical-functional change (e.g. unilateral hearing loss, malformation of the pinna) can disturb spatial hearing abilities. Many patients with hearing loss are fitted with a hearing aid (HA) or a cochlear implant (CI) to ensure the best speech understanding. However, this auditory rehabilitation remains insufficient to restore a good perception of spatial hearing. One of the key point to improve sound localization seems to be microphone positioning on hearing aids. Several questions remain on the optimal microphone positioning.
Status | Not yet recruiting |
Enrollment | 36 |
Est. completion date | June 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age 18 to 75 inclusive - Regular follow-up in the Ear Nose and Throat department of the Edouard Herriot hospital in Lyon - Post-lingual deafness - Fitted with two Advanced Bionics (AB) cochlear implants (Naïda Q70 or Naïda Q90 processor) Or fitted with one AB cochlear implant and a contralateral hearing aid - Fitted with the latest implant for more than 1 year - Normal or corrected vision - Able to understand experimental instructions - Affiliated with a social security scheme Exclusion Criteria: - Oculomotor disorder - Bilateral vestibular areflexia - Adult subject to a legal protection measure (guardianship, curatorship) |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Edouard Herriot - service ORL | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in 3d-D value at day 7 | We will compare 3d-D values obtained with baseline microphone position (at day 0) and 1 week after the first microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in SRT values and SSQ15 scores, these results will allow us to assess the effect of microphones positioning on spatial auditory performance. | Baseline and day 7 | |
Primary | Change from baseline in 3d-D value at day 14 | We will compare 3d-D values obtained with baseline microphone position (at day 0) and 1 week after the second microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in SRT values and SSQ15 scores, these results will allow us to assess the effect of microphones positioning on spatial auditory performance. | Baseline and day 14 | |
Primary | Change from baseline in SRT value at day 7 | We will compare SRT values obtained with baseline microphone position (at day 0) and 1 week after the first microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in 3d-D values and SSQ15 scores, these results will allow us to assess the effect of microphones positioning on spatial auditory performance. | Baseline and day 7 | |
Primary | Change from baseline in SRT value at day 14 | We will compare SRT values obtained with baseline microphone position (at day 0) and 1 week after the second microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in 3d-D values and SSQ15 scores, these results will allow us to assess the effect of microphones positioning on spatial auditory performance. | Baseline and day 14 | |
Primary | Change from baseline in SSQ15 score at day 7 | We will compare SSQ15 scores obtained with baseline microphone position (at day 0) and 1 week after the first microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in 3d-D values and SRT values, these results will allow us to assess the effect of microphones positioning on spatial auditory performance. | Baseline and day 7 | |
Primary | Change from baseline in SSQ15 score at day 14 | We will compare SSQ15 scores obtained with baseline microphone position (at day 0) and 1 week after the second microphone positioning change. Baseline microphone position is defined as the usual position at inclusion and might vary from one patient to another. Combined with change in 3d-D values and SRT values, these results will allow us to assess the effect of microphones positioning on spatial auditory performance. | Baseline and day 14 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study
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N/A | |
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