Programming Cochlear Implant With Artificial Intelligence (CI_AI)

October 8, 2018 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual fitting
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
The Clinician test the 22 electrodes so that the patient is able to hear the language
Experimental: Artificial Intelligence
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
The Clinician test the 22 electrodes so that the patient is able to hear the language

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2017

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 8, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/04SEP/427
  • 2017/13OCT/480 (Other Identifier: CEHF of Cliniques Universitaires Saint Luc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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