NCT06061458

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

September 14, 2023

Last Update Submit

September 30, 2023

Conditions

Hearing Impaired Children

Outcome Measures

Primary Outcomes (1)

  • speech process in the groups

    presence of the waves in the test traces

    30 minutes after the test

Secondary Outcomes (1)

  • best hearing amplification device

    30 minutes after the test

Study Arms (4)

control group

NO INTERVENTION

normal hearing

the group with hearing aids

EXPERIMENTAL

children with hearing aids

Diagnostic Test: speech auditory brainstem response

the group with cochlear implant

EXPERIMENTAL

children with cochlear implant

Diagnostic Test: speech auditory brainstem response

the group with bimodal hearing

EXPERIMENTAL

children with bimodal hearing

Diagnostic Test: speech auditory brainstem response

Interventions

speech auditory brainstem responseDIAGNOSTIC_TEST

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

the group with bimodal hearingthe group with cochlear implantthe group with hearing aids

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 36651959RESULT

  • 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.

    PMID: 20121865RESULT

  • 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.

    PMID: 10862922RESULT

  • 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.

    PMID: 20084007RESULT

  • 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.

    PMID: 18400899RESULT

  • 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.

    PMID: 34535280RESULT

  • 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.

    PMID: 7782180RESULT

Central Study Contacts

Amal Mohamed, professor

CONTACT

01003676677amalelattar99@yahoo.com

Enas Moustafa, lecturer

CONTACT

01061121765Enasosman101@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 29, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

October 3, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

The protocol