DeafnessNCT02331017
Assessment of Bimodal Contribution in Adult Cochlear Implant Users
A study testing Speech perception tests and self-rating questionnaire in people with Deafness, run by Bnai Zion Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deafness
- What is being tested?
- Speech perception tests and self-rating questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa
Talma Shpak, PhD, 97248359544, talma.shpak@b-zion.org.il
Noam Yehudai, MD
About this study
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.
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.
Read the 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.
- Conditions
- Deafness
- Being tested
- Speech perception tests and self-rating questionnaire
- Keywords
- Bimodal, Cochlear Implant, Hearing aid, Auditory Perception
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech perception tests and self-rating questionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Bimodal users | Experimental | 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 Receives: Behavioral: Speech perception tests and self-rating questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Assessment of functional performance in daily life using self-repot questionnaires
the Speech, Spatial and Quality (SSQ) questionnaire and the Hearing Handicap Questionnaire (HHQ).
Measured: 12 months
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MICHAL.LUNTZ, Bnai Zion Medical Center
- Investigators
- Michal Luntz, MD, Principal investigator, Bnai Zion Medica Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331017
- Sponsor's protocol ID
- BZ0084
- Status last verified
- Jan 2015
- First submitted
- 24 Dec 2014
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02331017
- Acronym / sponsor ID
- BZ0084
- Conditions
- Deafness
- Keywords
- Bimodal, Cochlear Implant, Hearing aid, Auditory Perception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bimodal users | Experimental | Behavioral: Speech perception tests and self-rating questionnaireBilateral-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech perception tests and self-rating questionnaireSpeech 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. | Behavioural | Bimodal users |
Primary outcome
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: 1. Semantically unpredictable sentence recognition presented from the front in the presence of a two-male-talker masker. 2. Horizontal right/left speech lateralization in quiet 3. Perception of monosyllabic words (HAB) in competing three-male-talker babble. 4. 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. 5. Perception of intonation. 6. Evaluation of the difference between the perception of natural prosody speech and the perception of speech with flattened F0 contour
2 secondary outcomes
Assessment of functional performance in daily life using self-repot questionnaires
Time frame: 12 months
Standard basic speech perception tests
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Luntz, MD principal investigator
Bnai Zion Medica Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech perception tests and self-rating questionnaire in people with Deafness, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Luntz, MD (97248359544, michal.luntz@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2015.