Clinical trial NCT04677517: Impact of Microphone Positioning on Auditory Performance in Cochlear Implant Users
Official title: Impact of Microphone Positioning on Auditory Performance in Cochlear Implant Users
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cochlear Prosthesis Implantation
Keywords: Cochlear implants users
microphone
virtual reality
spatial hearing perception
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change from baseline in 3d-D value at day 7
timeFrame: Baseline and day 7
measure: Change from baseline in 3d-D value at day 14
timeFrame: Baseline and day 14
measure: Change from baseline in SRT value at day 7
timeFrame: Baseline and day 7
measure: Change from baseline in SRT value at day 14
timeFrame: Baseline and day 14
measure: Change from baseline in SSQ15 score at day 7
timeFrame: Baseline and day 7
measure: Change from baseline in SSQ15 score at day 14
timeFrame: Baseline and day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot - service ORL
Study officials:
affiliation: Hospices Civils de Lyon
name: Eric TRUY, Professor
role: PRINCIPAL_INVESTIGATOR
References: