Back to resultsImproved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlea Implant User (APPIC)
Primary Purpose
Hearing Loss, Cochlear
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
S0N0
S0N500
S-500N500
S0N1000
S0Nuncorr
Sponsored by
About this trial
This is an interventional basic science trial for Hearing Loss, Cochlear focused on measuring Iteraural Time Difference
Eligibility Criteria
Inclusion Criteria:
- Fluent in local language
- Normal hearing listener:
- pure tone threshold > 25dB from 125Hz to 12kHz
- Cochlear implant recipient
- bilaterally implanted 6 months at least, the second implant should be implanted 6 months at least before participant inclusion
- Digisonic SP® cochlear implants user
Exclusion Criteria:
- binaural sensitivity threshold < 1000µs
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
bilateral cochlear implant recipients
normal hearing listners
Arm Description
Outcomes
Primary Outcome Measures
speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue
SRT is used as an outcome measure to quantify the acuity for speech perception in noise with Interaural Time Difference between the two ears. Signal recognition in a background noise is assessed the following conditions S0N0, S0N500, S0N1000, S-500N500 et S0Nuncorr. The noise level is constant at 65 dB SPL, the signal level is modified in the adaptive procedure in order to converge towards a score of 50% of correct response.
Secondary Outcome Measures
speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners
SRT is used as an outcome measure to quantify the acuity for speech perception in noise without Interaural Time Difference between the two ears.
ITD sensitivity in bilateral cochlear implant user
Speech signal and noise are presented at 65dB SPL. Participant adjust the Interaural Time Difference between the speech signal and noise between -1000 and +1000µs. Participant moves the cursor on the interface until he/she hear a difference in sound.
Preferred jitter in bilateral cochlear implant user
Speech signal and noise are presented at 65dB SPL. Participant adjust the jitter of the train pulse timing from 0 to +1000µs to improve the Interaural Time Difference.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04357704
Brief Title
Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlea Implant User
Acronym
APPIC
Official Title
Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlea Implant User
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Delay in setting up the study.
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical
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
The aim of the study is to evaluate the interaural time difference (ITD) benefit in patient with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners. Half of participants are bilateral cochlear implants users, while the other are normal hearing listeners.
Detailed Description
Listening in noisy environments is part of everyday life, it is based on binaural phenomena such as spatial localization
Bilateral cochlear implants certainly restore a part of binaurality
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Cochlear
Keywords
Iteraural Time Difference
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bilateral cochlear implant recipients
Arm Type
Experimental
Arm Title
normal hearing listners
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
S0N0
Intervention Description
(no ITD)
Intervention Type
Other
Intervention Name(s)
S0N500
Intervention Description
(ITD +500µs on noise)
Intervention Type
Other
Intervention Name(s)
S-500N500
Intervention Description
(ITD -500µs on signal and +500 µs on noise)
Intervention Type
Other
Intervention Name(s)
S0N1000
Intervention Description
(ITD + 1000 µs on noise)
Intervention Type
Other
Intervention Name(s)
S0Nuncorr
Intervention Description
(no ITD cue, with uncorrelated stimulation frame)
Primary Outcome Measure Information:
Title
speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue
Description
SRT is used as an outcome measure to quantify the acuity for speech perception in noise with Interaural Time Difference between the two ears. Signal recognition in a background noise is assessed the following conditions S0N0, S0N500, S0N1000, S-500N500 et S0Nuncorr. The noise level is constant at 65 dB SPL, the signal level is modified in the adaptive procedure in order to converge towards a score of 50% of correct response.
Time Frame
day 0
Secondary Outcome Measure Information:
Title
speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners
Description
SRT is used as an outcome measure to quantify the acuity for speech perception in noise without Interaural Time Difference between the two ears.
Time Frame
day 0
Title
ITD sensitivity in bilateral cochlear implant user
Description
Speech signal and noise are presented at 65dB SPL. Participant adjust the Interaural Time Difference between the speech signal and noise between -1000 and +1000µs. Participant moves the cursor on the interface until he/she hear a difference in sound.
Time Frame
day 0
Title
Preferred jitter in bilateral cochlear implant user
Description
Speech signal and noise are presented at 65dB SPL. Participant adjust the jitter of the train pulse timing from 0 to +1000µs to improve the Interaural Time Difference.
Time Frame
day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fluent in local language
Normal hearing listener:
pure tone threshold > 25dB from 125Hz to 12kHz
Cochlear implant recipient
bilaterally implanted 6 months at least, the second implant should be implanted 6 months at least before participant inclusion
Digisonic SP® cochlear implants user
Exclusion Criteria:
binaural sensitivity threshold < 1000µs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Guevara, MD
Organizational Affiliation
Hospital University Nice-IUFC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexis Bozorg-Grayeli, MD
Organizational Affiliation
Hospital University Dijon-François Mitterrand
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.oticonmedical.com
Description
oticon medical website
Learn more about this trial
Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlea Implant User
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