Cochlear ImplantsRACIS ABFNCT05369598
Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
A study testing Post-operative ABF followed by fitting according to clinical standard and Fitting according to clinical standard followed by post-operative ABF in people with Cochlear Implants and Sensorineural Hearing Loss, Bilateral, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implants, Sensorineural Hearing Loss, Bilateral
- What is being tested?
- Post-operative ABF followed by fitting according to clinical standard and Fitting according to clinical standard followed by post-operative ABF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2022to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Brussels, 1090
Vedat Topsakal, Prof
About this study
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.
- Being tested
- Post-operative ABF followed by fitting according to clinical standard, Fitting according to clinical standard followed by post-operative ABF
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative ABF followed by fitting according to clinical standardDevice
Cochlear implant will be fitted first with anatomy-based fitting for 6 months and followed by default fitting for 2 months.
Fitting according to clinical standard followed by post-operative ABFDevice
Cochlear implant will be fitted first with default fitting for 6 months and followed by anatomy-based fitting for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| ABF fitting followed by standard fitting | Active comparator | Not described Receives: Device: Post-operative ABF followed by fitting according to clinical standard |
| Standard fitting followed by ABF fitting | Active comparator | Not described Receives: Device: Fitting according to clinical standard followed by post-operative ABF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Measured: 3 months post- activation
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Measured: 6 months post- activation
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Measured: 8 months post-activation
Secondary outcomes (22)
Speech recognition in quiet: Percentage correctly identified phonemes
Measured: 3 months post-activation
Speech recognition in quiet: Percentage correctly identified phonemes
Measured: 6 months post-activation
Speech recognition in quiet: Percentage correctly identified phonemes
Measured: 8 months post-activation
Speech discrimination: Number of correctly discriminated pairs of phonemes
Measured: 3 months post- activation
Speech discrimination: Number of correctly discriminated pairs of phonemes
Measured: 6 months post- activation
Speech discrimination: Number of correctly discriminated pairs of phonemes
Measured: 8 months post- activation
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Measured: 1 month post- activation
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Measured: 3 month post- activation
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Measured: 6 months post- activation
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Measured: 8 months post- activation
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.
Measured: Baseline at activation
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.
Measured: 3 months post- activation
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.
Measured: 6 months post- activation
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.
Measured: 8 months post- activation
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.
Measured: Baseline at activation
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.
Measured: 3 months post- activation
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.
Measured: 6 months post- activation
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.
Measured: 8 months post- activation
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.
Measured: Baseline at activation
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.
Measured: 3 months post- activation
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.
Measured: 6 months post- activation
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.
Measured: 8 months post- activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Mar 2022
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vedat Topsakal, Prof., Principal investigator, UZB-VUB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369598
- Sponsor's protocol ID
- EC-2022-022
- Acronym
- RACIS ABF
- Status last verified
- Dec 2023
- First submitted
- 22 Mar 2022
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
- ClinicalTrials.gov ID
- NCT05369598
- Acronym / sponsor ID
- RACIS ABF / EC-2022-022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABF fitting followed by standard fitting | Active comparator | Device: Post-operative ABF followed by fitting according to clinical standard |
| Standard fitting followed by ABF fitting | Active comparator | Device: Fitting according to clinical standard followed by post-operative ABF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-operative ABF followed by fitting according to clinical standardCochlear implant will be fitted first with anatomy-based fitting for 6 months and followed by default fitting for 2 months. | Device | ABF fitting followed by standard fitting |
| Fitting according to clinical standard followed by post-operative ABFCochlear implant will be fitted first with default fitting for 6 months and followed by anatomy-based fitting for 2 months. | Device | Standard fitting followed by ABF fitting |
Primary outcome
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Time frame: 3 months post- activation
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Time frame: 6 months post- activation
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
Time frame: 8 months post-activation
22 secondary outcomes
Speech recognition in quiet: Percentage correctly identified phonemes
Time frame: 3 months post-activation
Speech recognition in quiet: Percentage correctly identified phonemes
Time frame: 6 months post-activation
Speech recognition in quiet: Percentage correctly identified phonemes
Time frame: 8 months post-activation
Speech discrimination: Number of correctly discriminated pairs of phonemes
Time frame: 3 months post- activation
Speech discrimination: Number of correctly discriminated pairs of phonemes
Time frame: 6 months post- activation
Speech discrimination: Number of correctly discriminated pairs of phonemes
Time frame: 8 months post- activation
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Time frame: 1 month post- activation
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Time frame: 3 month post- activation
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Time frame: 6 months post- activation
Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)
Time frame: 8 months post- activation
Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
Time frame: Baseline at activation
Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
Time frame: 3 months post- activation
Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
Time frame: 6 months post- activation
Patient reported outcome: Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain
Time frame: 8 months post- activation
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
Time frame: Baseline at activation
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
Time frame: 3 months post- activation
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
Time frame: 6 months post- activation
Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain
Time frame: 8 months post- activation
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time frame: Baseline at activation
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time frame: 3 months post- activation
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time frame: 6 months post- activation
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time frame: 8 months post- activation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vedat Topsakal, Prof. principal investigator
UZB-VUB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-operative ABF followed by fitting according to clinical standard and Fitting according to clinical standard followed by post-operative ABF in people with Cochlear Implants and Sensorineural Hearing Loss, Bilateral, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie Heuninck (024749772, emilie.heuninck@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR (time frame: 3 months post- activation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.