- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02331017
Assessment of Bimodal Contribution in Adult Cochlear Implant Users
Assessment of the Contribution of the Combined Acoustic Hearing Via a Hearing Aid and Electric Hearing Via a Cochlear Implant in Adult Bimodal Users With Moderate to Severe Residual Hearing in the Implanted and Non Implanted Ear.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Many current unilateral Cochlear Implant users have some residual acoustic hearing in the opposite ear as well as in the implanted ear. The amount of useful residual acoustic hearing varies among these implantees. There are several acoustic and electric combinations in the bilateral-bimodal listening mode depending on the amount of useful residual acoustic hearing in each ear. The combination of low frequency acoustic information provided by the hearing aid on each ear, completes the high frequency electric information provided by the Cochlear Implant (complementary bimodal benefit). Each of the different rehabilitation combinationsfor unilateral Cochlear Implant users enablesa unique integration of the three aspects of bilateral hearing bilaterality, binaurality and bimodality which may provide significant advantages over unilateral Cochlear Implant stimulation in terms of speech perception in noise, complementary information as well as localization abilities.
The study will include 20 bilateral-bimodal users with moderate-to-severe hearing loss at 250 Hz, 500 Hz and 1000 Hz in the non-implanted ear, who use hearing aids for at least 75% of their waking hours. Evaluation utilizes bilateral-binaural and bimodal complementary effects task-specific test batteries based on published doctoral research project. The assessment protocol consisted of tests that include various speech materials, different maskers, presentation of the noise from different locations in space, right/left speech lateralization, pitch-related tasks and subjective questionnaires. All tests will be administered in three listening conditions: Cochlear Implant -alone, hearing aid-alone and Cochlear Implant +hearing aid.
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
-
-
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Haifa, Israel
- Recruiting
- Bnai Zion Medical Center
-
Principal Investigator:
- Michal Luntz, MD
-
Contact:
- Talma Shpak, PhD
- Phone Number: 97248359544
- Email: talma.shpak@b-zion.org.il
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Sub-Investigator:
- Noam Yehudai, MD
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Sub-Investigator:
- Talma Shpak, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Bilateral-bimodal users
- With moderate-to-severe hearing loss at 250 Hz, 500 Hz and 1000 Hz in the non-implanted ear
- Who use hearing aids for at least 75% of their waking hours
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bimodal users
Bilateral-bimodal users with moderate-to-severe hearing loss who use hearing aids for at least 75% of their waking hours. Administration of Speech perception tests and self-rating questionnaire |
Speech perception test results and self-rating questionnaire scores will be analyzed by means of non-parametric statistical tests.
The statistical tests will be chosen in accordance with the number and type of variables in each test.
Correlation between audiological variables (aided and unaided hearing thresholds in the non implanted ear, aided speech perception abilities in the HA-alone condition) and the bilateral-bimodal benefit will be examined.
Moreover, possible relationship between self-rating questionnaire scores and speech perception test results will be assessed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech perception task specific tests using assessment protocol which will include 6 speech perception tests in quiet and noise listening conditions.
Time Frame: 12 months
|
ests designed to examine the contribution of bilateral-binaural benefits:
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of functional performance in daily life using self-repot questionnaires
Time Frame: 12 months
|
the Speech, Spatial and Quality (SSQ) questionnaire and the Hearing Handicap Questionnaire (HHQ).
|
12 months
|
Standard basic speech perception tests
Time Frame: 12 Months
|
Standard basic speech perception tests which will enable to characterize the basic speech perception abilities of the bilateral-bimodal users by means of a commonly utilized assessment tool: monosyllabic word discrimination on the Hebrew version of the AB Word List (HAB) in quiet; Hebrew version of the CID sentence recognition test in quiet and the Hebrew version of the CID sentence recognition test in the presence of four-talker-babble noise with the SNR fixed at +5dB, speech and noise presented from the front.
|
12 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michal Luntz, MD, Bnai Zion Medica 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
- BZ0084
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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