Speech Perception Performance With Gap-interleaved Stimulation Paradigms

Effect of Gap-interleaved Stimulation Paradigms in Speech Perception Performance of Experienced Cochlear Implant Recipients: a Single-centre, Randomised Controlled Single-blinded Study

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Deafness
• Intervention / Treatment: Other: Cochlear stimulation strategy including time-fixed gaps

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Geneva University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance in standardized speech perception tests	Consonant and word recognition tests	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of volume levels resulting in equal loudness perception	Energetic efficiency of stimulation map	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of hearing	1-10 visual-analog scale	Day 1

Collaborators and Investigators

• Sponsor: Angelica Perez Fornos
• Collaborators: University of Innsbruck / Department of Mechatronics
• Investigators: Principal Investigator: Angelica Perez Fornos, PhD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: electrical stimulation; cochlear implants; energy consumption; speech recognition; processing strategy; hearing quality
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 2018-01938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No