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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Speech Perception Performance With Gap-interleaved Stimulation Paradigms

Clinicaltrials.gov identifier NCT03937388

Recruitment Status Completed

First Posted May 3, 2019

Last update posted September 26, 2019

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.

  • Condition or Disease:Deafness
    Hearing Loss
  • Intervention/Treatment: Other: Cochlear stimulation strategy including time-fixed gaps
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 8 participants
  • 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 2019
  • Actual Primary Completion Date: June 2019
  • Actual Study Completion Date: June 2019
Arms and interventions
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.
Outcome Measures
  • 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
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

Switzerland
Geneva University Hospitals
Geneva

Sponsors and Collaborators

Angelica Perez Fornos

University of Innsbruck / Department of Mechatronics

Investigators

Principal Investigator: Angelica Perez Fornos, PhD University Hospital, Geneva

More Information
  • Responsible Party: Angelica Perez Fornos
  • ClinicalTrials.gov Identifier: NCT03937388 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Angelica Perez Fornos: processing strategy
    cochlear implants
    electrical stimulation
    hearing quality
    speech recognition
    energy consumption
  • Additional relevant MeSH terms: Hearing Loss Deafness