NCT02369718

Brief Summary

Cochlear implant microphones are subject to aging and dirtying. The evolution may affect their efficiency. Several signal coding strategies are used in cochlear implants and their behaviour may be more or less affected by the aging process. In this work the investigators wish to assess this phenomenon.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

January 22, 2015

Last Update Submit

August 26, 2025

Conditions

Hard of Hearing

Outcome Measures

Primary Outcomes (1)

  • Percentage of correct syllable recognition

    French "spondee lists"

    At day 1

Study Arms (2)

Implanted subjects

EXPERIMENTAL

Listening to 12 Fournier's lists of words

Other: Listening to 12 Fournier's lists of words

Normal hearing subjects

ACTIVE COMPARATOR

Listening to 48 Fournier's lists of words

Other: Listening to 48 Fournier's lists of words

Interventions

Listening to 12 Fournier's lists of wordsOTHER

Patients will listen to words from Fournier's lists of words in presence of noise presented at different Signal to Noise Ratio (SNR). 6 disyllable words Fournier's lists are presented to the implantees: SNRs ranged from 0 to 15 decibels (dBs) (0; 3; 6; 9; 12; 15) ; the subjects repeat orally the words. Then microphone is cleaned and, again, 6 Fournier's lists are presented.

Implanted subjects
Listening to 48 Fournier's lists of wordsOTHER

48 disyllable Fournier's lists of words are presented to the subjects (6 SNR\*2 coding strategies\*4 dirtying levels) and the subjects repeat orally the words. Dirtying levels will be simulated by sounds effects.

Normal hearing subjects

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • French speaking persons (French native speakers; studies made in French)
  • Ear, Nose and Throat (ENT) tests and check up for normal hearing listeners were normal (Hearing loss below 20 dBs for all frequencies situated in the 250-8000 Hz range)
  • Not mentally retarded

You may not qualify if:

  • Persons with tinnitus or headache
  • Anxious people (taking psychiatric drugs)
  • Mental alteration or mental retard
  • Deafened persons or taking an ENT treatment (normal hearing listeners)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pavillon ORL (U) - Hôpital Edouard Herriot

Lyon, 69437, France

Location

Related Publications (6)

  • P.A. Cucis, C. Berger-Vachon, E. Truy, H. Thai Van, F. Millioz, S. Gallego; "Cochlear Implants : Influence of the Coding Strategy on Syllable Recognition in Noise" AMSE JOURNALS-AMSE IFRATH Publication -2016: Modelling C; vol. 77; no 2; pp 84-97; 2016.

    BACKGROUND

  • P.A. Cucis, E. Veuillet, E. Truy, H. Thai Van, F. Millioz, S. Gallego; "Coding Strategy Robustness related to Microphone Integrityin Cochlear Implantsusing the Recognition of Syllables in a Noisy Environment"; AMSE JOURNALS-2016-Series: Advances B; vol. 59; no 1; pp 15-30; 2016.

    BACKGROUND

  • P.A. Cucis, E. Veuillet, E. Truy, H. Thai Van, F. Seldran, S. Gallego; "Effect of Microphone Cleaning on Syllable Recognition Performed by Cochlear Implant Users using the CIS and NofM Coding Strategies"; AMSE JOURNALS-2016-Series, Advances B; vol. 59; no 1; pp 31-45; 2016.

    BACKGROUND

  • P.A. Cucis, C. Berger-Vachon, E. Truy, H. Thai Van, F. Seldran, S. Gallego ; " Apport du nettoyage du microphone sur la reconnaissance de syllabes par des sujets implantés cochléaires selon les stratégies de codage CIS et N of M" ; Les Cahiers de l'Audition ; vol 29 ; no 5 ; pp 18-23 ; 2016.

    BACKGROUND

  • P.A. Cucis, C. Berger-Vachon, E. Truy, H. Thai Van, F. Millioz, S. Gallego " Influence de la stratégie de codage de l'implant cochléaire sur la reconnaissance de syllabes en milieu bruité en fonction de l'encrassement du microphone " Les Cahiers de l'Audition, vol 29, no 5, pp 12- 17, 2016.

    BACKGROUND

  • P.A. Cucis, C. Berger-Vachon, E. Truy, H. Thai Van, F. Millioz, S. Gallego; " Influence de la stratégie de codage de l'implant cochléaire sur la reconnaissance de syllabes en milieu bruité " Congrès Handicap 2016, IFRATH, Paris, 2016.

    BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 24, 2015

Study Start

November 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 3, 2025

Record last verified: 2025-08

Locations

FR(1)