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Speech Perception Performance With Gap-interleaved Stimulation Paradigms

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ClinicalTrials.gov Identifier: NCT03937388
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
University of Innsbruck / Department of Mechatronics
Information provided by (Responsible Party):
Angelica Perez Fornos, University Hospital, Geneva

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.

Condition or disease Intervention/treatment Phase
Deafness Hearing Loss Other: Cochlear stimulation strategy including time-fixed gaps Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Repeated measures, randomised, controlled, single blinded trial
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : March 6, 2019
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cochlear implant recipients Other: Cochlear stimulation strategy including time-fixed gaps
Investigation of the impact of time-fixed gaps (zero-stimulation periods) in the cochlear stimulation strategy on speech performance and hearing quality.




Primary Outcome Measures :
  1. Performance in standardized speech perception tests [ Time Frame: Day 1 ]
    Consonant and word recognition tests


Secondary Outcome Measures :
  1. Comparison of volume levels resulting in equal loudness perception [ Time Frame: Day 1 ]
    Energetic efficiency of stimulation map


Other Outcome Measures:
  1. Quality of hearing [ Time Frame: Day 1 ]
    1-10 visual-analog scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937388


Locations
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Switzerland
Geneva University Hospitals
Geneva, Switzerland, 1205
Sponsors and Collaborators
Angelica Perez Fornos
University of Innsbruck / Department of Mechatronics
Investigators
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Principal Investigator: Angelica Perez Fornos, PhD University Hospital, Geneva
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Responsible Party: Angelica Perez Fornos, Head of Engineering, Senior Lecturer, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03937388    
Other Study ID Numbers: 2018-01938
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angelica Perez Fornos, University Hospital, Geneva:
cochlear implants
electrical stimulation
processing strategy
hearing quality
speech recognition
energy consumption
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms