search
Back to results

Assessment of Bimodal Contribution in Adult Cochlear Implant Users

Primary Purpose

Deafness

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Speech perception tests and self-rating questionnaire
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deafness focused on measuring Bimodal, Cochlear Implant, Hearing aid, Auditory Perception

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Bnai Zion Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bimodal users

Arm Description

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

Outcomes

Primary Outcome Measures

Speech perception task specific tests using assessment protocol which will include 6 speech perception tests in quiet and noise listening conditions.
ests designed to examine the contribution of bilateral-binaural benefits: Semantically unpredictable sentence recognition presented from the front in the presence of a two-male-talker masker. Horizontal right/left speech lateralization in quiet Perception of monosyllabic words (HAB) in competing three-male-talker babble. Semantically unpredictable sentence recognition in the presence of one competing talker using a reversed speech sentence spoken by only two different talkers with different F0 characteristics. Perception of intonation. Evaluation of the difference between the perception of natural prosody speech and the perception of speech with flattened F0 contour

Secondary Outcome Measures

Assessment of functional performance in daily life using self-repot questionnaires
the Speech, Spatial and Quality (SSQ) questionnaire and the Hearing Handicap Questionnaire (HHQ).
Standard basic speech perception tests
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.

Full Information

First Posted
December 24, 2014
Last Updated
January 2, 2015
Sponsor
Bnai Zion Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02331017
Brief Title
Assessment of Bimodal Contribution in Adult Cochlear Implant Users
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bnai Zion Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the combination of electric hearing through Cochlear Implant and acoustic hearing through hearing aid in bimodal users with moderate-to-severe hearing loss in the non-implanted ear. The research will also provide pilot study data on unilateral Cochlear Implant recipients with residual useful acoustic hearing in the implanted ear whose acoustic hearing has been preserved.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness
Keywords
Bimodal, Cochlear Implant, Hearing aid, Auditory Perception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bimodal users
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Speech perception tests and self-rating questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Speech perception task specific tests using assessment protocol which will include 6 speech perception tests in quiet and noise listening conditions.
Description
ests designed to examine the contribution of bilateral-binaural benefits: Semantically unpredictable sentence recognition presented from the front in the presence of a two-male-talker masker. Horizontal right/left speech lateralization in quiet Perception of monosyllabic words (HAB) in competing three-male-talker babble. Semantically unpredictable sentence recognition in the presence of one competing talker using a reversed speech sentence spoken by only two different talkers with different F0 characteristics. Perception of intonation. Evaluation of the difference between the perception of natural prosody speech and the perception of speech with flattened F0 contour
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Assessment of functional performance in daily life using self-repot questionnaires
Description
the Speech, Spatial and Quality (SSQ) questionnaire and the Hearing Handicap Questionnaire (HHQ).
Time Frame
12 months
Title
Standard basic speech perception tests
Description
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.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Luntz, MD
Phone
97248359544
Email
michal.luntz@b-zion.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Noam Yehudai, MD
Phone
97248359544
Email
noam.yehudai@b-zion.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Luntz, MD
Organizational Affiliation
Bnai Zion Medica Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talma Shpak, PhD
Phone
97248359544
Email
talma.shpak@b-zion.org.il
First Name & Middle Initial & Last Name & Degree
Noam Yehudai, MD
First Name & Middle Initial & Last Name & Degree
Michal Luntz, MD
First Name & Middle Initial & Last Name & Degree
Talma Shpak, PhD

12. IPD Sharing Statement

Learn more about this trial

Assessment of Bimodal Contribution in Adult Cochlear Implant Users

We'll reach out to this number within 24 hrs