Programming Cochlear Implant With Artificial Intelligence

Not Applicable

• Conditions: Deafness; Perception
• Interventions: Other: Manual intervention to programme Cochlear Implant electrodes

• Registration Number: NCT03700268
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-04
• Status Verified: 2018-10
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-08
• Last Update Submitted: 2018-10-08
• Study First Posted: 2018-10-09
• Last Update Posted: 2018-10-09
• Primary Completion: 2020-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Manual fitting	Manual intervention to programme Cochlear Implant electrodes	The patient is receiving the classical treatment : 10 sessions of 1 hour during one year where the clinician programs manually the Cochlear implant.
Artificial Intelligence	Manual intervention to programme Cochlear Implant electrodes	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.

Primary Outcome Measures

Name	Time	Method
Evaluate Fox software efficiency	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).

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium