Speech Perception Performance With Gap-interleaved Stimulation Paradigms

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937388
• Other study ID #: 2018-01938
• Status: Completed
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 30, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Angelica Perez Fornos	University of Innsbruck / Department of Mechatronics

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of hearing	1-10 visual-analog scale	Day 1
Primary	Performance in standardized speech perception tests	Consonant and word recognition tests	Day 1
Secondary	Comparison of volume levels resulting in equal loudness perception	Energetic efficiency of stimulation map	Day 1