Speech Perception Performance With Gap-interleaved Stimulation Paradigms
Primary Purpose
Deafness, Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Cochlear stimulation strategy including time-fixed gaps
Sponsored by
About this trial
This is an interventional other trial for Deafness focused on measuring cochlear implants, electrical stimulation, processing strategy, hearing quality, speech recognition, energy consumption
Eligibility Criteria
Inclusion Criteria:
- Informed Consent as documented by signature
- CI recipients using MED-EL implants (C40+, Pulsar, Sonata, Concerto, or Synchrony) and standard electrode arrays (Standard, FLEXSOFT, FLEX28, or FLEX24)
- >1 year post-implantation
- Regular CI use (at least 4 hours/day)
- At least 9 active electrodes in the device
- Good knowledge of French (at least B1 level according to the Common European Framework of Reference for Languages)
Exclusion Criteria:
- Patients with electro-acoustic stimulation (EAS) systems
- Unwillingness or inability to perform investigational tests
- Known or suspected drug or alcohol abuse
- Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, dementia, etc.)
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Sites / Locations
- Geneva University Hospitals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cochlear implant recipients
Arm Description
Outcomes
Primary Outcome Measures
Performance in standardized speech perception tests
Consonant and word recognition tests
Secondary Outcome Measures
Comparison of volume levels resulting in equal loudness perception
Energetic efficiency of stimulation map
Full Information
NCT ID
NCT03937388
First Posted
April 30, 2019
Last Updated
September 25, 2019
Sponsor
Angelica Perez Fornos
Collaborators
University of Innsbruck / Department of Mechatronics
1. Study Identification
Unique Protocol Identification Number
NCT03937388
Brief Title
Speech Perception Performance With Gap-interleaved Stimulation Paradigms
Official Title
Effect of Gap-interleaved Stimulation Paradigms in Speech Perception Performance of Experienced Cochlear Implant Recipients: a Single-centre, Randomised Controlled Single-blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Angelica Perez Fornos
Collaborators
University of Innsbruck / Department of Mechatronics
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
Cochlear implants (CI) are used to help patients with severe to profound hearing loss regain auditory perception by electrical stimulation of the auditory nerve. The electrical stimulation consists of trains of charge balanced, biphasic current pulses. For each patient, individual stimulation parameters (perception threshold, most comfortable level - MCL) are determined for each electrode during fitting sessions. However, an important parameter, pulse duration, cannot be individualized for each electrode. There are certain circumstances where it would be advantageous to have the possibility of introducing variable pulse durations into the fitting strategy (e.g., optimization of energy consumption, development of combined cochleo-vestibular implants). However, since in current CI systems pulses are transmitted sequentially, introducing varying pulse widths would also introduce "gaps" (zero-stimulation periods) into the stimulation profile. The influence of such auditory gaps on speech recognition and on the quality of hearing has not been explored yet, but can be investigated in current CI users. The objective of this study is to investigate the impact of time-fixed gaps (zero-stimulation periods) in the cochlear stimulation strategy on speech performance and hearing quality.
Detailed Description
Auditory gaps can be induced in standard CI users by temporarily deactivating one to three electrodes. These gaps can be configured to have different gap durations.
The different variations of auditory stimulation with gaps will be presented to study participants via a standard MED-EL audio processor (Opus 2) bearing conformity marking. The programming of the processor will be performed using standard clinical hardware and software interfaces. These include the hardware interfaces "MAX interface box" and the "Diagnostic Interface Box" (DIB II) as well as the "MAESTRO" fitting software. After programming the respective configurations to the audio test-processor, a clinical word recognition test (Fournier) and a clinical consonant recognition test will be presented to the participants in a sound-shielded chamber using a free-field loudspeaker system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness, Hearing Loss
Keywords
cochlear implants, electrical stimulation, processing strategy, hearing quality, speech recognition, energy consumption
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Repeated measures, randomised, controlled, single blinded trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cochlear implant recipients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cochlear stimulation strategy including time-fixed gaps
Intervention Description
Investigation of the impact of time-fixed gaps (zero-stimulation periods) in the cochlear stimulation strategy on speech performance and hearing quality.
Primary Outcome Measure Information:
Title
Performance in standardized speech perception tests
Description
Consonant and word recognition tests
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Comparison of volume levels resulting in equal loudness perception
Description
Energetic efficiency of stimulation map
Time Frame
Day 1
Other Pre-specified Outcome Measures:
Title
Quality of hearing
Description
1-10 visual-analog scale
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed Consent as documented by signature
CI recipients using MED-EL implants (C40+, Pulsar, Sonata, Concerto, or Synchrony) and standard electrode arrays (Standard, FLEXSOFT, FLEX28, or FLEX24)
>1 year post-implantation
Regular CI use (at least 4 hours/day)
At least 9 active electrodes in the device
Good knowledge of French (at least B1 level according to the Common European Framework of Reference for Languages)
Exclusion Criteria:
Patients with electro-acoustic stimulation (EAS) systems
Unwillingness or inability to perform investigational tests
Known or suspected drug or alcohol abuse
Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, dementia, etc.)
Previous enrolment into the current study
Enrolment of the investigator, his/her family members, employees and other dependent persons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelica Perez Fornos, PhD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Speech Perception Performance With Gap-interleaved Stimulation Paradigms
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