search
Back to results

Improved 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Withdrawn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
Oticon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hearing Loss, Cochlear focused on measuring Iteraural Time Difference

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 27, 2018
    Last Updated
    April 21, 2020
    Sponsor
    Oticon Medical
    search

    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

    We'll reach out to this number within 24 hrs