Hearing Impaired ChildrenNCT06061458
Assessment of Children by Speech ABR
A study testing speech auditory brainstem response in people with Hearing Impaired Children, run by Assiut University.
Trial summary
Assessment of children by speech auditory brainstem response which is an objective method to study the speech development 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?
- speech auditory brainstem response
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Dec 2025
- 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
- Control group: (25) Children with normal peripheral hearing bilaterally their age is matched with the study group.
- Study group: three study groups, each study group has (25) children using, binaural Hearing aids, Cochlear implant and bimodal hearing with:
- Average IQ.
- No other congenital diseases affecting the speech progress.
- Using the hearing device for at least one year.
- Regular speech therapy sessions
Who cannot join
- Any other children not fulfilling the inclusion criteria or refuse to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Children With Variable Hearing Amplification Devices by Speech Auditory Brainstem Response
Assessment of children by speech auditory brainstem response which is an objective method to study the speech development
Read the detailed description
Hearing loss in children can result in cognitive deficits in the central areas which are dependent upon hearing, therefore responsible for delay in speech development, poor language skills and disorders in psychological and mental behavior. It will also cause a decrease of the intellectual ability and socio-economic position of the child.
In children aged 3.5 years and older, pure tone audiometry is performed to determine the exact frequency-specific hearing threshold.
To obtain the auditory threshold in younger children, Skoe and Kraus reported that the auditory brainstem response has proven to be a clinically useful tool for assessing neural function at the brainstem level and is most commonly elicited by clicks or tone-bursts.
However, recent research has established that complex stimuli can also elicit the response such as Music, complex tones, and speech stimuli . A speech stimulus is particularly useful, as it can provide clues as to how temporal and spectral features are preserved in the brainstem.
The human soundscape is characterized by complex sounds with rich harmonic structure, dynamic amplitude modulations and rapid spectro-temporal fluctuations. This complexity is represented by temporal and spectral neural code within the auditory brainstem, two broad classes of time-locked responses can be defined namely transient and sustained responses .
Although complex sounds consist of both sustained and transient features, the response to a complex sound is not necessarily predictable from the response to click auditory brainstem response . For these reason, further studies had gradually transitioned to using sounds as stimuli as they are more complex .
The click auditory brainstem response is a clinical tool to assess the neural functionality of the auditory brainstem. The use of verbal stimuli in auditory brainstem response protocols has provided important information of how the speech stimuli are processed by the brainstem structure .
The perception of speech sounds seems to begin in the brainstem, which has an important role in the reading process and the phonological acquisition . Speech auditory brainstem response assessment allows the identification of fine-grained auditory processing deficits associated with real world communication which do not appear in click evoked auditory brainstem response .
The verbal stimulus most widely used in speech auditory brainstem response is a syllable composed of a consonant and a vowel , usually the syllables da. The verbal assessment provides information about how the speech syllable is encoded by auditory system. The trace of the speech auditory brainstem response can be identified in two parts:
The onset and the frequency following response . The first part represents the consonant and the second part represents the vowel .
So speech auditory brainstem response can be used as an objective measure of the hearing function, one of the great advantages of this method is that it is not influenced by environmental issues, which can disrupt the behavioral assessments . Even the best behavioral tests can be affected by multiple factors such as attention, motivation and alertness or fatigue .
Moreover, altered responses of speech auditory brainstem response may be associated with impaired speech perception specially in noise. These changes can cause a negative impact on communication and serious consequences for academic success in children. complex auditory brainstem response can also help to identify those individuals who are most likely to benefit from auditory training .
- Conditions
- Hearing Impaired Children
- Being tested
- speech auditory brainstem response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech auditory brainstem responseDiagnostic test
A diagnostic objective test to evaluate the speech process in hearing impaired children
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | normal hearing |
| the group with hearing aids | Experimental | children with hearing aids Receives: Diagnostic Test: speech auditory brainstem response |
| the group with cochlear implant | Experimental | children with cochlear implant Receives: Diagnostic Test: speech auditory brainstem response |
| the group with bimodal hearing | Experimental | children with bimodal hearing Receives: Diagnostic Test: speech auditory brainstem response |
What is being measured
The primary outcome is the main question the study is designed to answer.
speech process in the groups
presence of the waves in the test traces
Measured: 30 minutes after the test
Secondary outcomes (1)
best hearing amplification device
best waves of the test traces
Measured: 30 minutes after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kholoud omar, MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061458
- Sponsor's protocol ID
- ACDS
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol
Publications
Basoz Behmen M, Guler N, Kuru E, Bal N, Gedik Toker O. Speech auditory brainstem response in audiological practice: a systematic review. Eur Arch Otorhinolaryngol. 2023 May;280(5):2099-2118. doi: 10.1007/s00405-023-07830-3. Epub 2023 Jan 18.
PubMed 36651959Basu M, Krishnan A, Weber-Fox C. Brainstem correlates of temporal auditory processing in children with specific language impairment. Dev Sci. 2010 Jan 1;13(1):77-91. doi: 10.1111/j.1467-7687.2009.00849.x.
PubMed 20121865Walch C, Anderhuber W, Kole W, Berghold A. Bilateral sensorineural hearing disorders in children: etiology of deafness and evaluation of hearing tests. Int J Pediatr Otorhinolaryngol. 2000 Jun 9;53(1):31-8. doi: 10.1016/s0165-5876(00)00307-4.
PubMed 10862922Skoe E, Kraus N. Auditory brain stem response to complex sounds: a tutorial. Ear Hear. 2010 Jun;31(3):302-24. doi: 10.1097/AUD.0b013e3181cdb272.
PubMed 20084007Johnson KL, Nicol T, Zecker SG, Kraus N. Developmental plasticity in the human auditory brainstem. J Neurosci. 2008 Apr 9;28(15):4000-7. doi: 10.1523/JNEUROSCI.0012-08.2008.
PubMed 18400899Hood LJ. Auditory Neuropathy/Auditory Synaptopathy. Otolaryngol Clin North Am. 2021 Dec;54(6):1093-1100. doi: 10.1016/j.otc.2021.07.004. Epub 2021 Sep 15.
PubMed 34535280Davis A, Fortnum H, O'Donoghue G. Children who could benefit from a cochlear implant: a European estimate of projected numbers, cost and relevant characteristics. Int J Pediatr Otorhinolaryngol. 1995 Mar;31(2-3):221-33. doi: 10.1016/0165-5876(94)01115-e.
PubMed 7782180
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Children With Variable Hearing Amplification Devices by Speech Auditory Brainstem Response
- ClinicalTrials.gov ID
- NCT06061458
- Acronym / sponsor ID
- ACDS
- Conditions
- Hearing Impaired Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 29 Sep 2023 (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.
Assessment of children by speech auditory brainstem response which is an objective method to study the speech development
Detailed description
Hearing loss in children can result in cognitive deficits in the central areas which are dependent upon hearing, therefore responsible for delay in speech development, poor language skills and disorders in psychological and mental behavior. It will also cause a decrease of the intellectual ability and socio-economic position of the child.
In children aged 3.5 years and older, pure tone audiometry is performed to determine the exact frequency-specific hearing threshold.
To obtain the auditory threshold in younger children, Skoe and Kraus reported that the auditory brainstem response has proven to be a clinically useful tool for assessing neural function at the brainstem level and is most commonly elicited by clicks or tone-bursts.
However, recent research has established that complex stimuli can also elicit the response such as Music, complex tones, and speech stimuli . A speech stimulus is particularly useful, as it can provide clues as to how temporal and spectral features are preserved in the brainstem.
The human soundscape is characterized by complex sounds with rich harmonic structure, dynamic amplitude modulations and rapid spectro-temporal fluctuations. This complexity is represented by temporal and spectral neural code within the auditory brainstem, two broad classes of time-locked responses can be defined namely transient and sustained responses .
Although complex sounds consist of both sustained and transient features, the response to a complex sound is not necessarily predictable from the response to click auditory brainstem response . For these reason, further studies had gradually transitioned to using sounds as stimuli as they are more complex .
The click auditory brainstem response is a clinical tool to assess the neural functionality of the auditory brainstem. The use of verbal stimuli in auditory brainstem response protocols has provided important information of how the speech stimuli are processed by the brainstem structure .
The perception of speech sounds seems to begin in the brainstem, which has an important role in the reading process and the phonological acquisition . Speech auditory brainstem response assessment allows the identification of fine-grained auditory processing deficits associated with real world communication which do not appear in click evoked auditory brainstem response .
The verbal stimulus most widely used in speech auditory brainstem response is a syllable composed of a consonant and a vowel , usually the syllables da. The verbal assessment provides information about how the speech syllable is encoded by auditory system. The trace of the speech auditory brainstem response can be identified in two parts:
The onset and the frequency following response . The first part represents the consonant and the second part represents the vowel .
So speech auditory brainstem response can be used as an objective measure of the hearing function, one of the great advantages of this method is that it is not influenced by environmental issues, which can disrupt the behavioral assessments . Even the best behavioral tests can be affected by multiple factors such as attention, motivation and alertness or fatigue .
Moreover, altered responses of speech auditory brainstem response may be associated with impaired speech perception specially in noise. These changes can cause a negative impact on communication and serious consequences for academic success in children. complex auditory brainstem response can also help to identify those individuals who are most likely to benefit from auditory training .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –normal hearing |
| the group with hearing aids | Experimental | Diagnostic Test: speech auditory brainstem responsechildren with hearing aids |
| the group with cochlear implant | Experimental | Diagnostic Test: speech auditory brainstem responsechildren with cochlear implant |
| the group with bimodal hearing | Experimental | Diagnostic Test: speech auditory brainstem responsechildren with bimodal hearing |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Control group: (25) Children with normal peripheral hearing bilaterally their age is matched with the study group.
- Study group: three study groups, each study group has (25) children using, binaural Hearing aids, Cochlear implant and bimodal hearing with:
- Average IQ.
- No other congenital diseases affecting the speech progress.
- Using the hearing device for at least one year.
Key exclusion criteria (1 listed)
- Any other children not fulfilling the inclusion criteria or refuse to participate in the study.
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 auditory brainstem responseA diagnostic objective test to evaluate the speech process in hearing impaired children | Diagnostic test | the group with bimodal hearing, the group with cochlear implant, the group with hearing aids |
Primary outcome
speech process in the groups
Time frame: 30 minutes after the test
presence of the waves in the test traces
1 secondary outcome
best hearing amplification device
Time frame: 30 minutes after the test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Results publication: PubMed 36651959Basoz Behmen M, Guler N, Kuru E, Bal N, Gedik Toker O. Speech auditory brainstem response in audiological practice: a systematic review. Eur Arch Otorhinolaryngol. 2023 May;280(5):2099-2118. doi: 10.1007/s00405-023-07830-3. Epub 2023 Jan 18.
- Results publication: PubMed 20121865Basu M, Krishnan A, Weber-Fox C. Brainstem correlates of temporal auditory processing in children with specific language impairment. Dev Sci. 2010 Jan 1;13(1):77-91. doi: 10.1111/j.1467-7687.2009.00849.x.
- Results publication: PubMed 10862922Walch C, Anderhuber W, Kole W, Berghold A. Bilateral sensorineural hearing disorders in children: etiology of deafness and evaluation of hearing tests. Int J Pediatr Otorhinolaryngol. 2000 Jun 9;53(1):31-8. doi: 10.1016/s0165-5876(00)00307-4.
- Results publication: PubMed 20084007Skoe E, Kraus N. Auditory brain stem response to complex sounds: a tutorial. Ear Hear. 2010 Jun;31(3):302-24. doi: 10.1097/AUD.0b013e3181cdb272.
- Results publication: PubMed 18400899Johnson KL, Nicol T, Zecker SG, Kraus N. Developmental plasticity in the human auditory brainstem. J Neurosci. 2008 Apr 9;28(15):4000-7. doi: 10.1523/JNEUROSCI.0012-08.2008.
- Results publication: PubMed 34535280Hood LJ. Auditory Neuropathy/Auditory Synaptopathy. Otolaryngol Clin North Am. 2021 Dec;54(6):1093-1100. doi: 10.1016/j.otc.2021.07.004. Epub 2021 Sep 15.
- Results publication: PubMed 7782180Davis A, Fortnum H, O'Donoghue G. Children who could benefit from a cochlear implant: a European estimate of projected numbers, cost and relevant characteristics. Int J Pediatr Otorhinolaryngol. 1995 Mar;31(2-3):221-33. doi: 10.1016/0165-5876(94)01115-e.
- Individual participant dataSharing planned: No. The protocol
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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.
Questions about this trial
What is this clinical trial studying?
A study testing speech auditory brainstem response 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 6 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 3 Oct 2023. 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 Amal Mohamed, professor (01003676677, amalelattar99@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
speech process in the groups (time frame: 30 minutes after the test). 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 NCT06061458, which also lists 7 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 3 Oct 2023.