Deafness; PerceptionCI_AINCT03700268
Programming Cochlear Implant With Artificial Intelligence
A study testing Manual intervention to programme Cochlear Implant electrodes in people with Deafness; Perception, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This thesis project proposes to investigate the "state of the art" of the programming of the cochlear implant. In the center of audiophonologie Brussels, the classic 'manual programming' has been in use over 20 years and also the new way 'Artificial Intelligence programming'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deafness; Perception
- What is being tested?
- Manual intervention to programme Cochlear Implant electrodes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Sep 2017to Sep 2021
- 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
- unilateral cochlear implant
- post-lingual hearing loss
- a good command of French.
Who cannot join
- non deaf
- bilateral cochlear implant
- deaf without cochlear implant
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Justine Wathour, +3227643169, justine.wathour@uclouvain.be
About this study
This thesis project proposes to investigate the "state of the art" of the programming of the cochlear implant. In the center of audiophonologie Brussels, the classic 'manual programming' has been in use over 20 years and also the new way 'Artificial Intelligence programming'. The investigators want to compare, objectify, and control this new mode of programming.
The study is planned over 4 years, in order to test, randomized, 15 subjects with manual programming and 15 other subjects with Artificial Intelligence programming. To test the performance of Cochlear Implant patients, audiological, language auditory perception and questionnaire tests will be presented.
This research aims to determine the contribution and results of Artificial Intelligence programming.
- Conditions
- Deafness; Perception
- Being tested
- Manual intervention to programme Cochlear Implant electrodes
- Keywords
- Deafness, cochlear implant, Artificial Intelligence
- Medical subject headings
- Hearing Loss, Sensorineural, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual intervention to programme Cochlear Implant electrodesOther
The Clinician test the 22 electrodes so that the patient is able to hear the language
| Study group | Role | What they receive |
|---|---|---|
| Manual fitting | Experimental | The patient is receiving the classical treatment : 10 sessions of 1 hour during one year where the clinician programs manually the Cochlear implant. Receives: Other: Manual intervention to programme Cochlear Implant electrodes |
| Artificial Intelligence | Experimental | The patient is receiving the new treatment : 4 sessions of 1 hour during one year where the clinician programs the Cochlear implant with the FOX (Fitting to Outcome eXpert) software using artificial intelligence. Receives: Other: Manual intervention to programme Cochlear Implant electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Fox software efficiency
Evaluate Fox software efficiency for the programming of Cochlear implants used to facilitate hearing of deaf patients. This research aims to determine the contribution (time, results,…) of Artificial intelligence to program cochlear implants. The investigator will compare the results of hearing tests of newly programmed patients with FOX to those of newly programmed patients with a manual fitting.
The outcomes used by software FOX are pure tone audiometry thresholds from 250 to 6000Hz, speech audiometry scores at 40, 55, 70 and 85 dB SPL, spectral discrimination scores using an oddity test in which 2 speech sounds are presented and where the aim is to react to the odd speech sound (Govaerts et al. 2006), and loudness growth curves determined with narrow band noises centered at 250, 1000 and 4000 Hz using an A§E® test battery (Meeuws et al., 2017).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start4 Sep 2017
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deafness; PerceptionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700268
- Sponsor's protocol ID
- 2017/04SEP/427
- Other IDs
- 2017/13OCT/480
- Acronym
- CI_AI
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wathour J, Govaerts PJ, Lacroix E, Naima D. Effect of a CI Programming Fitting Tool with Artificial Intelligence in Experienced Cochlear Implant Patients. Otol Neurotol. 2023 Mar 1;44(3):209-215. doi: 10.1097/MAO.0000000000003810. Epub 2023 Jan 18.
PubMed 36728126Wathour J, Govaerts PJ, Deggouj N. Variability of fitting parameters across cochlear implant centres. Eur Arch Otorhinolaryngol. 2021 Dec;278(12):4671-4679. doi: 10.1007/s00405-020-06572-w. Epub 2021 Jan 3.
PubMed 33388985Wathour J, Govaerts PJ, Deggouj N. From manual to artificial intelligence fitting: Two cochlear implant case studies. Cochlear Implants Int. 2020 Sep;21(5):299-305. doi: 10.1080/14670100.2019.1667574. Epub 2019 Sep 17.
PubMed 31530099
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programming Cochlear Implant With Artificial Intelligence
- ClinicalTrials.gov ID
- NCT03700268
- Acronym / sponsor ID
- CI_AI / 2017/04SEP/427
- Conditions
- Deafness; Perception
- Keywords
- Deafness, cochlear implant, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 9 Oct 2018 (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.
This thesis project proposes to investigate the "state of the art" of the programming of the cochlear implant. In the center of audiophonologie Brussels, the classic 'manual programming' has been in use over 20 years and also the new way 'Artificial Intelligence programming'. The investigators want to compare, objectify, and control this new mode of programming.
The study is planned over 4 years, in order to test, randomized, 15 subjects with manual programming and 15 other subjects with Artificial Intelligence programming. To test the performance of Cochlear Implant patients, audiological, language auditory perception and questionnaire tests will be presented.
This research aims to determine the contribution and results of Artificial Intelligence programming.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual fitting | Experimental | Other: Manual intervention to programme Cochlear Implant electrodesThe patient is receiving the classical treatment : 10 sessions of 1 hour during one year where the clinician programs manually the Cochlear implant. |
| Artificial Intelligence | Experimental | Other: Manual intervention to programme Cochlear Implant electrodesThe patient is receiving the new treatment : 4 sessions of 1 hour during one year where the clinician programs the Cochlear implant with the FOX (Fitting to Outcome eXpert) software using artificial intelligence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- unilateral cochlear implant
- post-lingual hearing loss
- a good command of French.
Key exclusion criteria (3 listed)
- non deaf
- bilateral cochlear implant
- deaf without cochlear implant
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 |
|---|---|---|
| Manual intervention to programme Cochlear Implant electrodesThe Clinician test the 22 electrodes so that the patient is able to hear the language | Other | Artificial Intelligence, Manual fitting |
Primary outcome
Evaluate Fox software efficiency
Time frame: 1 year
Evaluate Fox software efficiency for the programming of Cochlear implants used to facilitate hearing of deaf patients. This research aims to determine the contribution (time, results,…) of Artificial intelligence to program cochlear implants. The investigator will compare the results of hearing tests of newly programmed patients with FOX to those of newly programmed patients with a manual fitting. The outcomes used by software FOX are pure tone audiometry thresholds from 250 to 6000Hz, speech audiometry scores at 40, 55, 70 and 85 dB SPL, spectral discrimination scores using an oddity test in which 2 speech sounds are presented and where the aim is to react to the odd speech sound (Govaerts et al. 2006), and loudness growth curves determined with narrow band noises centered at 250, 1000 and 4000 Hz using an A§E® test battery (Meeuws et al., 2017).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 36728126Wathour J, Govaerts PJ, Lacroix E, Naima D. Effect of a CI Programming Fitting Tool with Artificial Intelligence in Experienced Cochlear Implant Patients. Otol Neurotol. 2023 Mar 1;44(3):209-215. doi: 10.1097/MAO.0000000000003810. Epub 2023 Jan 18.
- Derived from this study: PubMed 33388985Wathour J, Govaerts PJ, Deggouj N. Variability of fitting parameters across cochlear implant centres. Eur Arch Otorhinolaryngol. 2021 Dec;278(12):4671-4679. doi: 10.1007/s00405-020-06572-w. Epub 2021 Jan 3.
- Derived from this study: PubMed 31530099Wathour J, Govaerts PJ, Deggouj N. From manual to artificial intelligence fitting: Two cochlear implant case studies. Cochlear Implants Int. 2020 Sep;21(5):299-305. doi: 10.1080/14670100.2019.1667574. Epub 2019 Sep 17.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual intervention to programme Cochlear Implant electrodes in people with Deafness; Perception, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain 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 3 inclusion and 3 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 9 Oct 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Fox software efficiency (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700268, which also lists 3 linked publications.
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 9 Oct 2018.