Programming Cochlear Implant With Artificial Intelligence

Deafness; Perception Clinical Trial

— CI_AI  

Official title:

Programming Cochlear Implant With Artificial Intelligence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03700268
• Other study ID #: 2017/04SEP/427
• Secondary ID: 2017/13OCT/480
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: September 2021

Study information

• Verified date: October 2018
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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'. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Deafness; Perception
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Other:
• Manual intervention to programme Cochlear Implant electrodes
The Clinician test the 22 electrodes so that the patient is able to hear the language

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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