Speech Perception Performance With Gap-interleaved Stimulation Paradigms

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03937388
Study type	Interventional
Source	University Hospital, Geneva
Contact
Status	Completed
Phase	N/A
Start date	March 6, 2019
Completion date	June 30, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04696835` - fNIRS in Pediatric Hearing Aids	N/A
Completed	`NCT03662256` - Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine	N/A
Completed	`NCT04602780` - Evaluating the Revised WORQ in CI Users
Completed	`NCT03723161` - Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
Completed	`NCT05086809` - Investigation of an Updated Bone-anchored Sound Processor	N/A
Active, not recruiting	`NCT03548779` - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2	N/A
Completed	`NCT03428841` - Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients	N/A
Completed	`NCT04559282` - Home Test of New Sound Processor	N/A
Enrolling by invitation	`NCT03345654` - Individually-guided Hearing Aid Fitting
Completed	`NCT06016335` - MRI-based Synthetic CT Images of the Head and Neck	N/A
Completed	`NCT05165121` - Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids	N/A
Recruiting	`NCT05533840` - Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Terminated	`NCT02294812` - Effects of Cognitive Training on Speech Perception	N/A
Completed	`NCT04622059` - AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis	N/A
Recruiting	`NCT02558478` - Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing	N/A
Withdrawn	`NCT02740322` - Validating the Hum Test	N/A
Completed	`NCT01963104` - Community-Based Kiosks for Hearing Screening and Education	N/A
Completed	`NCT01892007` - Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users	N/A
Completed	`NCT01857661` - The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial	N/A
Withdrawn	`NCT01223638` - The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.