- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02323932
Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michal Luntz, MD
- Phone Number: 97248359544
- Email: michal.luntz@b-zion.org.il
Study Contact Backup
- Name: Noam Yehudai, MD
- Phone Number: 97248359544
- Email: noam.yehudai@b-zion.org.il
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- Bnzi Zion Medical Center
-
Principal Investigator:
- Michal Luntz, MD
-
Contact:
- Talma Shpak, PhD
- Phone Number: 97248359544
- Email: talma.shpak@b-zion.org.il
-
Sub-Investigator:
- Noam Yehudai, MD
-
Sub-Investigator:
- Talma Shpak, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Bilateral cochlear implant users
- Bilateral-bimodal users who use hearing aids for at least 75% of their waking hours.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
The amount of change in the fundamental frequency that was required in order to identify a question
|
Active Comparator: 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.
|
The amount of change in the fundamental frequency that was required in order to identify a question
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The amount of change in the fundamental frequency that was required in order to identify a question
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michal Luntz, MD, Bnai Zion Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BZ0085
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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