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Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users

NCT ID: NCT02323932

Last Updated: 2014-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to evaluate the benefit of bimodal hearing and bilateral cochlear implant hearing in comparison to unilateral cochlear implant hearing in the perception of speech intonation.

Detailed Description

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Bilateral hearing which is a fundamental characteristic of normal auditory system provides significant advantages in adverse listening conditions. In cochlear implant users, binaural hearing can be achieved via bilateral cochlear implant (CI/CI) or binaural-bimodal stimulation, i.e. a cochlear implant in one ear and a hearing aid in the other (CI/HA). It is assumed that CI/CI hearing and CI/HA hearing differ with respect to their physiological sources and functional benefit. Although both hearing prosthesis (CI/CI or CI/HA) lack several of the features needed to allow listeners to experience the full binaural advantage conferred by a normal-hearing auditory system it can, however, provide significant advantages over the use of a unilateral hearing prosthesis. Most of the accepted assessment clinical materials are not sensitive enough to evaluate the contribution of binaural hearing rehabilitation via CI/CI or CI/HA hearing for the perception of intonation. In a previous study the perception of intonation was evaluated in 29 adults CI/HA users via a closed-set format design with the same target talker. The results of the study showed small bimodal benefit. The test paradigm was apparently an easy task for the adult listeners and not sensitive enough to show the expected CI/HA bimodal benefit over cochlear implant alone.

The perception of correct intonation identification will be computed for each listener in each of the listening conditions. The amount of change in the fundamental frequency that was required in order to identify a question will be computed for each listener in each of the conditions. ANOVA with repeated measures will be used to assess the differences among the conditions for each group as well as the differences among the groups.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Bilateral Cochlear implant users

The perception of intonation will be assessed through the use of 2 tests. In the first test, listeners will have to identify statements and yes/no questions that will be presented by male and female talkers in the background of four- talkers-babble noise comprised of two females and two males. In the second test, listeners will be presented with gradual changes in the fundamental frequency of a sentence. They will be required to identify the sentence with each of the changes as a statement or a question. Each of the 2 tests will be presented in three listening conditions: each of the CI alone and bilateral (CI/CI) conditions.

Group Type ACTIVE_COMPARATOR

Perception of correct intonation identification

Intervention Type BEHAVIORAL

The amount of change in the fundamental frequency that was required in order to identify a question

Bimodal Cochlear implant users

The perception of intonation will be assessed through the use of 2 tests. In the first test, listeners will have to identify statements and yes/no questions that will be presented by male and female talkers in the background of four- talkers-babble noise comprised of two females and two males. In the second test, listeners will be presented with gradual changes in the fundamental frequency of a sentence. They will be required to identify the sentence with each of the changes as a statement or a question. Each of the 2 tests will be presented in three listening conditions: CI alone, HA alone and bimodal (CI/HA) conditions.

Group Type ACTIVE_COMPARATOR

Perception of correct intonation identification

Intervention Type BEHAVIORAL

The amount of change in the fundamental frequency that was required in order to identify a question

Interventions

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Perception of correct intonation identification

The amount of change in the fundamental frequency that was required in order to identify a question

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Bilateral cochlear implant users
* Bilateral-bimodal users who use hearing aids for at least 75% of their waking hours.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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MICHAL.LUNTZ

Head of Otolaryngology Head and Neck Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michal Luntz, MD

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medical Center

Locations

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Bnzi Zion Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Michal Luntz, MD

Role: CONTACT

Phone: 97248359544

Email: [email protected]

Noam Yehudai, MD

Role: CONTACT

Phone: 97248359544

Email: [email protected]

Facility Contacts

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Talma Shpak, PhD

Role: primary

Other Identifiers

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BZ0085

Identifier Type: -

Identifier Source: org_study_id