Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related MeasuresNCT05684393
Anatomy-based Fitting in Unexperienced Cochlear Implant Users
A study testing frequency distribution type in people with Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures, run by Dominik Riss at 1 site in Austria.
Trial summary
The present study investigates CI users' potential differences in speech tests, other performance measures (i.e. pitch-matching, perception of timbre and melodic intervals, consonance perception), and patient-reported outcome (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures
- What is being tested?
- frequency distribution type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2023to Jul 2024
- 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
- Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
- Post-OP CT scan of the CI electrode available
- Subject implanted with MED-EL cochlear implant(s)
- Subjects received a Flex28, FlexSoft and 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
Show all 10Show fewer
- 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 ICF before the start of any study-specific procedure
Who cannot join
- Lack of compliance with any inclusion criteria
- EAS user (user of an EAS audio processor)
- Implanted with C40+, C40X and C40C
- Implanted with an ABI or Split electrode array
- 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.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1180
Dominik Riss, MD, +4314040033760, dominik.riss@meduniwien.ac.at
Dominik Riss, MD
About this study
The present study investigates CI users' potential differences in speech tests, other performance measures (i.e. pitch-matching, perception of timbre and melodic intervals, consonance perception), and patient-reported outcome (i.e. questionnaires) between the clinical fitting map and anatomy-based fitting in two groups of CI users (one with standard fitting and one with anatomy-based fitting).
- Conditions
- Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures
- Being tested
- frequency distribution type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frequency distribution typeOther
One group is fitted using channel filterbank frequency distribution based on anatomy data extracted from post-OP CT measurements. The second (control) group is fitted with the standard frequency distribution used in MAESTRO 9 fitting software.
| Study group | Role | What they receive |
|---|---|---|
| Anatomy based fitting | Experimental | Not described Receives: Other: frequency distribution type |
| Standard fitting | Active comparator | Not described Receives: Other: frequency distribution type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Word recognition score (WRS)
Percentage of correctly understood monosyllabic words from a list.
Measured: 6 months
Secondary outcomes (5)
Speech reception threshold (SRT)
German matrix sentence test - speech to noise ratio in dB.
Measured: 6 months
Pitch ranking
Difference of the mean ranks for a set of frequencies presented to the tested CI ear and the reference ear.
Measured: 6 months
Perception of timbre
Visual Analog Scale ratings describing the difference in timbre between the tested CI ear and the reference ear when listening to audio.
Measured: 6 months
Phoneme categorization
Shape of the psychometric function describing the perception of the /s/-/ʃ/ continuum.
Measured: 6 months
Consonance/difference rating
The degree of modulation of the pleasantness-score across the individual intervals.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related MeasuresStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The performance with the CI is investigated over time in two groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9 fitting software. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dominik Riss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dominik Riss, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684393
- Sponsor's protocol ID
- 2131/2021
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomy-based Fitting in Unexperienced Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT05684393
- Acronym / sponsor ID
- 2131/2021
- Conditions
- Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dominik RissUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 13 Jan 2023 (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.
The present study investigates CI users' potential differences in speech tests, other performance measures (i.e. pitch-matching, perception of timbre and melodic intervals, consonance perception), and patient-reported outcome (i.e. questionnaires) between the clinical fitting map and anatomy-based fitting in two groups of CI users (one with standard fitting and one with anatomy-based fitting).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The performance with the CI is investigated over time in two groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9 fitting software. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9.
| Arm | Type | Receives |
|---|---|---|
| Anatomy based fitting | Experimental | Other: frequency distribution type |
| Standard fitting | Active comparator | Other: frequency distribution type |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
- Post-OP CT scan of the CI electrode available
- Subject implanted with MED-EL cochlear implant(s)
- Subjects received a Flex28, FlexSoft and Standard electrode
- Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side
Key exclusion criteria (5 listed)
- Lack of compliance with any inclusion criteria
- EAS user (user of an EAS audio processor)
- Implanted with C40+, C40X and C40C
- Implanted with an ABI or Split electrode array
- 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 |
|---|---|---|
| frequency distribution typeOne group is fitted using channel filterbank frequency distribution based on anatomy data extracted from post-OP CT measurements. The second (control) group is fitted with the standard frequency distribution used in MAESTRO 9 fitting software. | Other | Anatomy based fitting, Standard fitting |
Primary outcome
Word recognition score (WRS)
Time frame: 6 months
Percentage of correctly understood monosyllabic words from a list.
5 secondary outcomes
Speech reception threshold (SRT)
Time frame: 6 months
Pitch ranking
Time frame: 6 months
Perception of timbre
Time frame: 6 months
Phoneme categorization
Time frame: 6 months
Consonance/difference rating
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing frequency distribution type in people with Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures, run by Dominik Riss at 1 site in Austria.
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 10 inclusion and 5 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 13 Jan 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 Austria. 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 Dominik Riss, MD (+43 1 40400 33760, dominik.riss@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word recognition score (WRS) (time frame: 6 months). 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 13 Jan 2023; AzTrials last refreshed its copy on 28 Oct 2026.