- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02369718
Cochlear Implants : Influence of Microphone Aging and Dirtying
February 14, 2017 updated by: Hospices Civils de Lyon
Consequences of Aging and Dirtying of Microphones on the Performances of Cochlear Implants. Influence of Signal Coding
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
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
-
-
-
LYON cedex 03, France, 69437
- Pavillon ORL (U) - Hôpital Edouard Herriot
-
-
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 to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
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: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Implanted subjects
Listening to 12 Fournier's lists of words
|
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.
|
Active Comparator: Normal hearing subjects
Listening to 48 Fournier's lists of words
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of correct syllable recognition
Time Frame: At day 1
|
French "spondee lists"
|
At day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2014
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
January 22, 2015
First Submitted That Met QC Criteria
February 17, 2015
First Posted (Estimate)
February 24, 2015
Study Record Updates
Last Update Posted (Actual)
February 15, 2017
Last Update Submitted That Met QC Criteria
February 14, 2017
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014.873
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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