Hearing Impaired Children Clinical Trial
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
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2025 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 12 Years |
Eligibility | 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 Exclusion Criteria: • Any other children not fulfilling the inclusion criteria or refuse to participate in the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | speech process in the groups | presence of the waves in the test traces | 30 minutes after the test | |
Secondary | best hearing amplification device | best waves of the test traces | 30 minutes after the test |
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