Impact of Microphone Positioning on Auditory Performance in Cochlear Implant Users

Cochlear Prosthesis Implantation Clinical Trial

— MICLO  

Official title:

Impact of Microphone Positioning on Auditory Performance in Cochlear Implant Users

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04677517
• Other study ID #: 69HCL20_1013
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: August 2021
• Source: Hospices Civils de Lyon
• Contact: Eric TRUY, Professor
• Phone: +33(0)4 72 11 04 92
• Email: eric.truy[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Cochlear Prosthesis Implantation

Intervention

Device:
• Modification of active microphone positioning
Patient will pass the experimental tests described above with 3 different active microphone positions : on the cochlear implant processor; on the antenna in front of the external ear canal Patient will pass the tests 1 week after each microphone position change, so that they can get used to the new position in their everyday life.

Behavioral:
• SPHERE protocol
Patient's 3D localization in noise will be assessed thnks to a 3D localization system called SPHERE based on virtual reality. Data from spatial hearing perception will be recorded in three-dimensional space (azimuth, elevation, and depth). First, the pointing error will be computed separately for azimuth, elevation, and depth, in terms of constant error (absolute and signed) and variable error. Then, these separate errors will be combined into a cumulative error "3d-D" (the 3d-D value), hence summarizing all three space dimensions, and taking into account absolute and variable error in one measure.
• French Matrix Test
This test assesses the intelligibility threshold defined as the noise level (in decibels) for which the subject can repeat 50% of the words heard (in dichotic listening), resulting in an Speech Recognition Threshold (SRT) value
• Quality of life questionnaire
The Speech, Spatial and Qualities of Hearing Scale short-form with 15 items (SSQ15) questionnaire is performed in order to evaluate auditory abilities of patients in different daily life situations.
• Likert scale
This subjective evaluation will be added to evaluate difficulties and self-confidence felt by participants during the SPHERE protocol and the French Matrix Test.

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot - service ORL	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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