Back to resultsCochlear Implants : Influence of Microphone Aging and Dirtying
Primary Purpose
Hard of Hearing
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Listening to 12 Fournier's lists of words
Listening to 48 Fournier's lists of words
Sponsored by
About this trial
This is an interventional prevention trial for Hard of Hearing
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Pavillon ORL (U) - Hôpital Edouard Herriot
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Implanted subjects
Normal hearing subjects
Arm Description
Listening to 12 Fournier's lists of words
Listening to 48 Fournier's lists of words
Outcomes
Primary Outcome Measures
Percentage of correct syllable recognition
French "spondee lists"
Secondary Outcome Measures
Full Information
NCT ID
NCT02369718
First Posted
January 22, 2015
Last Updated
February 14, 2017
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02369718
Brief Title
Cochlear Implants : Influence of Microphone Aging and Dirtying
Official Title
Consequences of Aging and Dirtying of Microphones on the Performances of Cochlear Implants. Influence of Signal Coding
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hard of Hearing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Implanted subjects
Arm Type
Experimental
Arm Description
Listening to 12 Fournier's lists of words
Arm Title
Normal hearing subjects
Arm Type
Active Comparator
Arm Description
Listening to 48 Fournier's lists of words
Intervention Type
Other
Intervention Name(s)
Listening to 12 Fournier's lists of words
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Listening to 48 Fournier's lists of words
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of correct syllable recognition
Description
French "spondee lists"
Time Frame
At day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Facility Information:
Facility Name
Pavillon ORL (U) - Hôpital Edouard Herriot
City
LYON cedex 03
ZIP/Postal Code
69437
Country
France
12. IPD Sharing Statement
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Cochlear Implants : Influence of Microphone Aging and Dirtying
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