Impact of Microphone Positioning on Auditory Performance in Cochlear Implant Users

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 75 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Cochlear Prosthesis Implantation

Being tested

Modification of active microphone positioning, SPHERE protocol, French Matrix Test, Quality of life questionnaire, Likert scale

Keywords

Cochlear implants users, microphone, virtual reality, spatial hearing perception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Modification of active microphone positioningDevice

  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.

• SPHERE protocolBehavioural

  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 TestBehavioural

  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 questionnaireBehavioural

  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 scaleBehavioural

  This subjective evaluation will be added to evaluate difficulties and self-confidence felt by participants during the SPHERE protocol and the French Matrix Test.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Baseline and day 7

2. 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.

   Measured: Baseline and day 14

3. 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.

   Measured: Baseline and day 7

4. 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.

   Measured: Baseline and day 14

5. 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.

   Measured: Baseline and day 7

6. 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.

   Measured: Baseline and day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted21 Dec 2020
2. Study start1 Dec 2022 (estimated)
3. Primary completion1 Jun 2023 (estimated)
4. Study completion1 Jun 2023 (estimated)

Why it stopped: The project has been replaced by anotherone with a different regulatory qualification

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Cochlear Prosthesis ImplantationStudies of the same condition, open and under way.
• More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.