Assessment of Children by Speech ABR

NCT ID: NCT06061458

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-12-01

Brief Summary

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Assessment of children by speech auditory brainstem response which is an objective method to study the speech development

Detailed Description

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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

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Hearing Impaired Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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control group

normal hearing

Group Type NO_INTERVENTION

No interventions assigned to this group

the group with hearing aids

children with hearing aids

Group Type EXPERIMENTAL

speech auditory brainstem response

Intervention Type DIAGNOSTIC_TEST

A diagnostic objective test to evaluate the speech process in hearing impaired children

the group with cochlear implant

children with cochlear implant

Group Type EXPERIMENTAL

speech auditory brainstem response

Intervention Type DIAGNOSTIC_TEST

A diagnostic objective test to evaluate the speech process in hearing impaired children

the group with bimodal hearing

children with bimodal hearing

Group Type EXPERIMENTAL

speech auditory brainstem response

Intervention Type DIAGNOSTIC_TEST

A diagnostic objective test to evaluate the speech process in hearing impaired children

Interventions

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speech auditory brainstem response

A diagnostic objective test to evaluate the speech process in hearing impaired children

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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kholoud omar, MD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amal Mohamed, professor

Role: CONTACT

01003676677

Enas Moustafa, lecturer

Role: CONTACT

01061121765

References

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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.

Reference Type RESULT
PMID: 36651959 (View on PubMed)

Basu 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.

Reference Type RESULT
PMID: 20121865 (View on PubMed)

Walch 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.

Reference Type RESULT
PMID: 10862922 (View on PubMed)

Skoe 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.

Reference Type RESULT
PMID: 20084007 (View on PubMed)

Johnson 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.

Reference Type RESULT
PMID: 18400899 (View on PubMed)

Hood 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.

Reference Type RESULT
PMID: 34535280 (View on PubMed)

Davis 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.

Reference Type RESULT
PMID: 7782180 (View on PubMed)

Other Identifiers

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ACDS

Identifier Type: -

Identifier Source: org_study_id

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