NCT03700268

Brief 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'. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

October 4, 2018

Last Update Submit

October 8, 2018

Conditions

Deafness; Perception

Keywords

Deafnesscochlear implantArtificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 year

Study Arms (2)

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.

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.

Other: Manual intervention to programme Cochlear Implant electrodes

Interventions

Manual intervention to programme Cochlear Implant electrodesOTHER

The Clinician test the 22 electrodes so that the patient is able to hear the language

Artificial IntelligenceManual fitting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral cochlear implant
  • post-lingual hearing loss
  • a good command of French.

You may not qualify if:

  • non deaf
  • bilateral cochlear implant
  • deaf without cochlear implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (3)

  • 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.

    PMID: 36728126DERIVED

  • Wathour 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.

    PMID: 33388985DERIVED

  • Wathour 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.

    PMID: 31530099DERIVED

MeSH Terms

Conditions

Hearing Loss, SensorineuralDeafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 9, 2018

Study Start

September 4, 2017

Primary Completion

September 1, 2020

Study Completion

September 1, 2021

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)