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Anatomy-Based Fitting in Unexperienced Cochlear Implant Users (ABFmulti)

Primary Purpose

Cochlear Implants, Sensorineural Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Default CI fitting
Anatomy-based CI fitting
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cochlear Implants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
  • Post-operative Computed Tomography (CT) scan of the CI electrode available
  • Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
  • Subject implanted with MED-EL cochlear implant(s)
  • Subjects received a Flex28, FlexSoft or Standard electrode
  • Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side
  • Audio processor not yet activated on the newly implanted side
  • The most apical active electrode contact has to be inserted at least 450°
  • Minimum of 10 active channels can be activated
  • Fluent in the language of the test centre
  • Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure

Exclusion Criteria:

  • Lack of compliance with any inclusion criteria
  • Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)
  • Implanted with C40+, C40X and C40C
  • Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array
  • Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study

Sites / Locations

  • UZ BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Default CI fitting

Anatomy-based CI fitting

Arm Description

Programming of cochlear implant speech processor according to standard clinical care

Programming of cochlear implant speech processor with anatomy-based fitting

Outcomes

Primary Outcome Measures

Speech recognition test in quiet (S0): percentage correctly identified phonemes
Speech recognition test in quiet (S0): percentage correctly identified phonemes

Secondary Outcome Measures

Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
Result of the pitch matching test: frequency difference in semitones
Result of the pitch matching test: frequency differences in semitones
Result of the perception of timbre test: Score on Visual Analog Scale (VAS)
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.
Result of the perception of timbre test: Score on Visual Analog Scale (VAS)
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure
Result of the speech contrast discrimination test: Psychometric function of phoneme categorization
Result of the speech contrast discrimination test: Psychometric function of phoneme categorization
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Datalogging data: Average numbers of hours per day
Datalogging data: Average numbers of hours per day
Datalogging data: Average numbers of hours per day
Datalogging data: Average numbers of hours per day

Full Information

First Posted
June 2, 2022
Last Updated
July 8, 2022
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT05451628
Brief Title
Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
Acronym
ABFmulti
Official Title
Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cochlear Implants, Sensorineural Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Default CI fitting
Arm Type
Active Comparator
Arm Description
Programming of cochlear implant speech processor according to standard clinical care
Arm Title
Anatomy-based CI fitting
Arm Type
Active Comparator
Arm Description
Programming of cochlear implant speech processor with anatomy-based fitting
Intervention Type
Device
Intervention Name(s)
Default CI fitting
Intervention Description
Programming of cochlear implant speech processor according to standard clinical care
Intervention Type
Device
Intervention Name(s)
Anatomy-based CI fitting
Intervention Description
Programming of cochlear implant speech processor with anatomy-based fitting
Primary Outcome Measure Information:
Title
Speech recognition test in quiet (S0): percentage correctly identified phonemes
Time Frame
3 months post-activation
Title
Speech recognition test in quiet (S0): percentage correctly identified phonemes
Time Frame
6 months post-activation
Secondary Outcome Measure Information:
Title
Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
Time Frame
3 months post-activation
Title
Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
Time Frame
6 months post-activation
Title
Result of the pitch matching test: frequency difference in semitones
Time Frame
3 months post-activation
Title
Result of the pitch matching test: frequency differences in semitones
Time Frame
6 months post-activation
Title
Result of the perception of timbre test: Score on Visual Analog Scale (VAS)
Description
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.
Time Frame
3 months post-activation
Title
Result of the perception of timbre test: Score on Visual Analog Scale (VAS)
Description
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.
Time Frame
6 months post-activation
Title
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure
Time Frame
3 months post-activation
Title
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure
Time Frame
6 months post-activation
Title
Result of the speech contrast discrimination test: Psychometric function of phoneme categorization
Time Frame
3 months post-activation
Title
Result of the speech contrast discrimination test: Psychometric function of phoneme categorization
Time Frame
6 months post-activation
Title
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time Frame
1 day visit (At the activation of the sound processor)
Title
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time Frame
3 months post-activation
Title
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time Frame
6 months post-activation
Title
Datalogging data: Average numbers of hours per day
Time Frame
2 weeks post-activation
Title
Datalogging data: Average numbers of hours per day
Time Frame
1 months post-activation
Title
Datalogging data: Average numbers of hours per day
Time Frame
3 months post-activation
Title
Datalogging data: Average numbers of hours per day
Time Frame
6 months post-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s) Post-operative Computed Tomography (CT) scan of the CI electrode available Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available Subject implanted with MED-EL cochlear implant(s) Subjects received a Flex28, FlexSoft or Standard electrode Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side Audio processor not yet activated on the newly implanted side The most apical active electrode contact has to be inserted at least 450° Minimum of 10 active channels can be activated Fluent in the language of the test centre Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure Exclusion Criteria: Lack of compliance with any inclusion criteria Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor) Implanted with C40+, C40X and C40C Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie Heuninck, MD
Phone
+3224749772
Email
emilie.heuninck@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vedat Topsakal, Prof.
Organizational Affiliation
UZB-VUB
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vedat Topsakal, Prof
First Name & Middle Initial & Last Name & Degree
Emilie Heuninck, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

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