Hearing Impaired ChildrenNCT04093830
Bimodal Stimulation Compared to Unilateral Cochlear Implant
A study testing hearing aid in people with Hearing Impaired Children, run by Assiut University.
Trial summary
The majority of studies about bimodal hearing advantages have been conducted on adults but scant relevant studies into pediatric users, therefore more comparative studies are required to compare the effect of bimodal stimulation to unilateral cochlear implant use in children with severe to profound sensori-neural… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Jan 2022
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The lack of middle-ear infection.
- Normative intelligence.
- The lack of auditory neuropathy disorder .
- Residual hearing in the non-implanted ear.
Who cannot join
- Middle ear infection..
- Below average intelligence.
- Auditory neuropathy disorder.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Advantages of Bimodal Stimulation Compared to Unilateral Cochlear Implant Use in Children With Hearing Loss
The majority of studies about bimodal hearing advantages have been conducted on adults but scant relevant studies into pediatric users, therefore more comparative studies are required to compare the effect of bimodal stimulation to unilateral cochlear implant use in children with severe to profound sensori-neural hearing loss .
Read the detailed description
There are now many recipients of unilateral cochlear implants who have usable residual hearing in the non-implanted ear. To avoid auditory deprivation and to provide binaural hearing, a hearing aid or a second cochlear implant can be fitted to that ear. When bilateral cochlear implant cannot be used for patients with bilateral hearing impairment, a hearing aid can be used in their non- implanted ear with residual hearing. This is because patients with bilateral hearing loss need bilateral stimulation to develop the neural pathway required for central processing of binaural hearing.
- Conditions
- Hearing Impaired Children
- Being tested
- hearing aid
- Keywords
- Hearing Loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hearing aidDevice
hearing aid can be used in their non- implanted ear with residual hearing
| Study group | Role | What they receive |
|---|---|---|
| pre-lingually deafened children with cochlear implant | Experimental | pre-lingually deafened children with cochlear implant who continuously used bimodal hearing. Receives: Device: hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone condition
By using pure tone and speech audiometer the pure tone audiometry will be done in the free field with a speaker at 0° azimuth and the mean threshold in speech frequencies of 0.5, 1, 2 and 4 kilohertz will be determined.
Measured: Baseline
Comparison between speech discrimination score in bimodal fitting condition and cochlear implant alone condition.
The speech discrimination score is a measure as a percentage of words from a standardized list presented at suprathreshold levels that are recognized and repeated by the patient.
a higher score on the speech discrimination test is better
Interpreting speech discrimination score :
100-90% Means Excellent or Normal speech discrimination score, 89-75% Means Good speech discrimination score, 74-60% Means Fair speech discrimination score, 59-50 % Means Poor speech discrimination score\& <50% Means Very Poor speech discrimination score.
Measured: Baseline
Evaluation of speech perception ability in noise under bimodal fitting a condition and cochlear implant alone condition
By speech perception in noise (SPIN) test using Compact disc on compact discs player.
Measured: Baseline
Comparison of early speech perception in bimodal fitting condition and cochlear implant alone condition
The test will be done starting from a low level using the manual and standard scoring forms of Early speech perception test ( ESP) by using : Compact disc , full-color picture cards, Toys ,digitally remastered sounds, and an All Words menu
Measured: Baseline
Comparison between the speech reception threshold in bimodal fitting condition and cochlear implant alone condition.
Speech reception threshold is the minimum intensity in decibels at which a patient can understand 50% of spoken words from a closed set list of disyllabic words
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing Impaired ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Rizk Fam, Assiut University
- Investigators
- Enass S Mohamed, Professor, Principal investigator, Professor of Audio-vestibular medicine,Assiut University,Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093830
- Sponsor's protocol ID
- bimodal hearing
- Status last verified
- Jan 2020
- First submitted
- 6 Sep 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dorman MF, Gifford RH, Spahr AJ, McKarns SA. The benefits of combining acoustic and electric stimulation for the recognition of speech, voice and melodies. Audiol Neurootol. 2008;13(2):105-12. doi: 10.1159/000111782. Epub 2007 Nov 29.
PubMed 18057874Kokkinakis K, Pak N. Binaural advantages in users of bimodal and bilateral cochlear implant devices. J Acoust Soc Am. 2014 Jan;135(1):EL47-53. doi: 10.1121/1.4831955.
PubMed 24437856Tao DD, Liu JS, Yang ZD, Wilson BS, Zhou N. Bilaterally Combined Electric and Acoustic Hearing in Mandarin-Speaking Listeners: The Population With Poor Residual Hearing. Trends Hear. 2018 Jan-Dec;22:2331216518757892. doi: 10.1177/2331216518757892.
PubMed 29451107
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advantages of Bimodal Stimulation Compared to Unilateral Cochlear Implant Use in Children With Hearing Loss
- ClinicalTrials.gov ID
- NCT04093830
- Acronym / sponsor ID
- bimodal hearing
- Conditions
- Hearing Impaired Children
- Keywords
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 18 Sep 2019 (actual)
- 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.
The majority of studies about bimodal hearing advantages have been conducted on adults but scant relevant studies into pediatric users, therefore more comparative studies are required to compare the effect of bimodal stimulation to unilateral cochlear implant use in children with severe to profound sensori-neural hearing loss .
Detailed description
There are now many recipients of unilateral cochlear implants who have usable residual hearing in the non-implanted ear. To avoid auditory deprivation and to provide binaural hearing, a hearing aid or a second cochlear implant can be fitted to that ear. When bilateral cochlear implant cannot be used for patients with bilateral hearing impairment, a hearing aid can be used in their non- implanted ear with residual hearing. This is because patients with bilateral hearing loss need bilateral stimulation to develop the neural pathway required for central processing of binaural hearing.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pre-lingually deafened children with cochlear implant | Experimental | Device: hearing aidpre-lingually deafened children with cochlear implant who continuously used bimodal hearing. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The lack of middle-ear infection.
- Normative intelligence.
- The lack of auditory neuropathy disorder .
- Residual hearing in the non-implanted ear.
Key exclusion criteria (3 listed)
- Middle ear infection..
- Below average intelligence.
- Auditory neuropathy disorder.
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 |
|---|---|---|
| hearing aidhearing aid can be used in their non- implanted ear with residual hearing | Device | pre-lingually deafened children with cochlear implant |
Primary outcome
Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone condition
Time frame: Baseline
By using pure tone and speech audiometer the pure tone audiometry will be done in the free field with a speaker at 0° azimuth and the mean threshold in speech frequencies of 0.5, 1, 2 and 4 kilohertz will be determined.
Comparison between speech discrimination score in bimodal fitting condition and cochlear implant alone condition.
Time frame: Baseline
The speech discrimination score is a measure as a percentage of words from a standardized list presented at suprathreshold levels that are recognized and repeated by the patient. a higher score on the speech discrimination test is better Interpreting speech discrimination score : 100-90% Means Excellent or Normal speech discrimination score, 89-75% Means Good speech discrimination score, 74-60% Means Fair speech discrimination score, 59-50 % Means Poor speech discrimination score\& <50% Means Very Poor speech discrimination score.
Evaluation of speech perception ability in noise under bimodal fitting a condition and cochlear implant alone condition
Time frame: Baseline
By speech perception in noise (SPIN) test using Compact disc on compact discs player.
Comparison of early speech perception in bimodal fitting condition and cochlear implant alone condition
Time frame: Baseline
The test will be done starting from a low level using the manual and standard scoring forms of Early speech perception test ( ESP) by using : Compact disc , full-color picture cards, Toys ,digitally remastered sounds, and an All Words menu
Comparison between the speech reception threshold in bimodal fitting condition and cochlear implant alone condition.
Time frame: Baseline
Speech reception threshold is the minimum intensity in decibels at which a patient can understand 50% of spoken words from a closed set list of disyllabic words
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Background: PubMed 18057874Dorman MF, Gifford RH, Spahr AJ, McKarns SA. The benefits of combining acoustic and electric stimulation for the recognition of speech, voice and melodies. Audiol Neurootol. 2008;13(2):105-12. doi: 10.1159/000111782. Epub 2007 Nov 29.
- Background: PubMed 24437856Kokkinakis K, Pak N. Binaural advantages in users of bimodal and bilateral cochlear implant devices. J Acoust Soc Am. 2014 Jan;135(1):EL47-53. doi: 10.1121/1.4831955.
- Background: PubMed 29451107Tao DD, Liu JS, Yang ZD, Wilson BS, Zhou N. Bilaterally Combined Electric and Acoustic Hearing in Mandarin-Speaking Listeners: The Population With Poor Residual Hearing. Trends Hear. 2018 Jan-Dec;22:2331216518757892. doi: 10.1177/2331216518757892.
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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.
Enass S Mohamed, Professor principal investigator
Professor of Audio-vestibular medicine,Assiut University,Egypt.
Questions about this trial
What is this clinical trial studying?
A study testing hearing aid in people with Hearing Impaired Children, run by Assiut University.
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 4 inclusion and 3 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Mariam R Fam, Resident (01008630890, mariamrizkfam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone condition (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04093830, which also lists 3 linked publications.
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 18 Jan 2020.