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Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS) (RACIS ABF)

Primary Purpose

Cochlear Implants, Sensorineural Hearing Loss, Bilateral

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Post-operative ABF followed by fitting according to clinical standard
Fitting according to clinical standard followed by post-operative ABF
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)
  • Subject implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
  • Subject implanted with MED-EL cochlear implant(s) with Flex28, Flex 26 or FlexSoft electrode to obtain maximum cochlear coverage
  • Subject planned to receive a MED-EL SONNET 2 or RONDO 3 audio processor on the newly implanted side
  • Subject is either a user with unilateral implantation, bilateral implantation or a bimodal CI user (unilateral CI user with contralateral ear adequately fitted with a hearing aid)
  • Pre- operative and post-operative CT scan of the temporal bone available
  • Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
  • Audio processor not yet activated on the newly implanted side
  • Minimum of 10 active channels can be activated
  • Fluent in the language of the test centre (Dutch or French)
  • Signed and dated ICF before the start of any study-specific procedure

Exclusion Criteria:

  • Subject is a Single-Sided Deafness (SSD) CI user
  • Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor)
  • Lack of compliance with any inclusion criteria
  • Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude 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

ABF fitting followed by standard fitting

Standard fitting followed by ABF fitting

Arm Description

Outcomes

Primary Outcome Measures

Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR

Secondary Outcome Measures

Speech recognition in quiet: Percentage correctly identified phonemes
Speech recognition in quiet: Percentage correctly identified phonemes
Speech recognition in quiet: Percentage correctly identified phonemes
Speech discrimination: Number of correctly discriminated pairs of phonemes
Speech discrimination: Number of correctly discriminated pairs of phonemes
Speech discrimination: Number of correctly discriminated pairs of phonemes
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from "Never" to "Always" (Statement 1-55) or from "No" to "Quite well" (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items.For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome.
Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from "Never" to "Always" (Statement 1-55) or from "No" to "Quite well" (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items.For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome.
Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from "Never" to "Always" (Statement 1-55) or from "No" to "Quite well" (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items.For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome.
Patient reported outcome: Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from "Never" to "Always" (Statement 1-55) or from "No" to "Quite well" (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items. For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome.
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.

Full Information

First Posted
March 22, 2022
Last Updated
July 13, 2022
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT05369598
Brief Title
Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
Acronym
RACIS ABF
Official Title
Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (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. This study will focus on patients that are already implanted with the HEARO robotic system.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ABF fitting followed by standard fitting
Arm Type
Active Comparator
Arm Title
Standard fitting followed by ABF fitting
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Post-operative ABF followed by fitting according to clinical standard
Intervention Description
Cochlear implant will be fitted first with anatomy-based fitting for 6 months and followed by default fitting for 2 months.
Intervention Type
Device
Intervention Name(s)
Fitting according to clinical standard followed by post-operative ABF
Intervention Description
Cochlear implant will be fitted first with default fitting for 6 months and followed by anatomy-based fitting for 2 months.
Primary Outcome Measure Information:
Title
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Time Frame
3 months post- activation
Title
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Time Frame
6 months post- activation
Title
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Time Frame
8 months post-activation
Secondary Outcome Measure Information:
Title
Speech recognition in quiet: Percentage correctly identified phonemes
Time Frame
3 months post-activation
Title
Speech recognition in quiet: Percentage correctly identified phonemes
Time Frame
6 months post-activation
Title
Speech recognition in quiet: Percentage correctly identified phonemes
Time Frame
8 months post-activation
Title
Speech discrimination: Number of correctly discriminated pairs of phonemes
Time Frame
3 months post- activation
Title
Speech discrimination: Number of correctly discriminated pairs of phonemes
Time Frame
6 months post- activation
Title
Speech discrimination: Number of correctly discriminated pairs of phonemes
Time Frame
8 months post- activation
Title
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Time Frame
1 month post- activation
Title
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Time Frame
3 month post- activation
Title
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Time Frame
6 months post- activation
Title
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Time Frame
8 months post- activation
Title
Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
Description
The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from "Never" to "Always" (Statement 1-55) or from "No" to "Quite well" (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items.For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome.
Time Frame
Baseline at activation
Title
Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
Description
The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from "Never" to "Always" (Statement 1-55) or from "No" to "Quite well" (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items.For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome.
Time Frame
3 months post- activation
Title
Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
Description
The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from "Never" to "Always" (Statement 1-55) or from "No" to "Quite well" (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items.For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome.
Time Frame
6 months post- activation
Title
Patient reported outcome: Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
Description
The physical domain comprises three subdomains, namely Basic sound perception, Advanced sound perception, and Speech production. The Psychological domain contains the subdomain Self-esteem and the Social domain handles questions about Activity limitations and Social interactions. Each subdomain covers 10 statements. Each statement is rated on a 5-point Likert scale ranging from "Never" to "Always" (Statement 1-55) or from "No" to "Quite well" (Statement 56-60). Scores for the subdomains will be computed by transforming the answer categories (1-5) for all items: 1 = 0, 2 = 25, 3 = 50, 4 = 75, and 5 = 100 and by adding together the 10-item scores of each subdomain and dividing by the number of completed items. For each subdomain, the score ranges between 0-100 and a higher score indicates a better outcome.
Time Frame
8 months post- activation
Title
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
Description
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Time Frame
Baseline at activation
Title
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
Description
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Time Frame
3 months post- activation
Title
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
Description
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Time Frame
6 months post- activation
Title
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
Description
The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores on these 12 items.For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Time Frame
8 months post- activation
Title
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Description
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
Time Frame
Baseline at activation
Title
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Description
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good 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
Description
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
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
Description
The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
Time Frame
8 months post- activation
Other Pre-specified Outcome Measures:
Title
Evaluation of electrode contact location: Degrees of deviation
Time Frame
8th 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) Subject implanted by Robot Assisted Cochlear Implant Surgery (RACIS) Subject implanted with MED-EL cochlear implant(s) with Flex28, Flex 26 or FlexSoft electrode to obtain maximum cochlear coverage Subject planned to receive a MED-EL SONNET 2 or RONDO 3 audio processor on the newly implanted side Subject is either a user with unilateral implantation, bilateral implantation or a bimodal CI user (unilateral CI user with contralateral ear adequately fitted with a hearing aid) Pre- operative and post-operative CT scan of the temporal bone available Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available Audio processor not yet activated on the newly implanted side Minimum of 10 active channels can be activated Fluent in the language of the test centre (Dutch or French) Signed and dated ICF before the start of any study-specific procedure Exclusion Criteria: Subject is a Single-Sided Deafness (SSD) CI user Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor) Lack of compliance with any inclusion criteria Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude 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
024749772
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)

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