Impact of Microphone Positioning on Auditory Performance in Cochlear Implant Users

Not Applicable

Withdrawn

• Conditions: Cochlear Prosthesis Implantation
• Interventions: Device: Modification of active microphone positioning; Behavioral: SPHERE protocol; Behavioral: French Matrix Test; Behavioral: Quality of life questionnaire; Behavioral: Likert scale

• Registration Number: NCT04677517
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-21
• Study Start: 2022-12-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Oculomotor disorder
• Bilateral vestibular areflexia
• Adult subject to a legal protection measure (guardianship, curatorship)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implanted patients	French Matrix Test	All the participants are patients with post-lingual deafness and fitted with cochlear implants
Implanted patients	Quality of life questionnaire	All the participants are patients with post-lingual deafness and fitted with cochlear implants
Implanted patients	Likert scale	All the participants are patients with post-lingual deafness and fitted with cochlear implants
Implanted patients	SPHERE protocol	All the participants are patients with post-lingual deafness and fitted with cochlear implants
Implanted patients	Modification of active microphone positioning	All the participants are patients with post-lingual deafness and fitted with cochlear implants

Primary Outcome Measures

Name	Time	Method
Change from baseline in 3d-D value at day 14	Baseline and 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.
Change from baseline in SRT value at day 14	Baseline and 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.
Change from baseline in 3d-D value at day 7	Baseline and 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.
Change from baseline in SRT value at day 7	Baseline and 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.
Change from baseline in SSQ15 score at day 7	Baseline and 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.
Change from baseline in SSQ15 score at day 14	Baseline and 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.

Trial Locations

Locations (1)

Hôpital Edouard Herriot - service ORL; 🇫🇷 Lyon, France