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Programming Cochlear Implant With Artificial Intelligence (CI_AI)

Primary Purpose

Deafness; Perception

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Manual intervention to programme Cochlear Implant electrodes
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deafness; Perception focused on measuring Deafness, cochlear implant, Artificial Intelligence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques Universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Manual fitting

Artificial Intelligence

Arm Description

The patient is receiving the classical treatment : 10 sessions of 1 hour during one year where the clinician programs manually the Cochlear implant.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 4, 2018
Last Updated
October 8, 2018
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03700268
Brief Title
Programming Cochlear Implant With Artificial Intelligence
Acronym
CI_AI
Official Title
Programming Cochlear Implant With Artificial Intelligence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness; Perception
Keywords
Deafness, cochlear implant, Artificial Intelligence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual fitting
Arm Type
Experimental
Arm Description
The patient is receiving the classical treatment : 10 sessions of 1 hour during one year where the clinician programs manually the Cochlear implant.
Arm Title
Artificial Intelligence
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual intervention to programme Cochlear Implant electrodes
Intervention Description
The Clinician test the 22 electrodes so that the patient is able to hear the language
Primary Outcome Measure Information:
Title
Evaluate Fox software efficiency
Description
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).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine Wathour
Phone
+3227643169
Email
justine.wathour@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33388985
Citation
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.
Results Reference
derived
PubMed Identifier
31530099
Citation
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.
Results Reference
derived

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Programming Cochlear Implant With Artificial Intelligence

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