Auditory Steady State Response vsAuditory Brainstem Response

Hearing Impaired Children Clinical Trial

Official title:

[ASSR] in Hearing Impaired Children With Absent [ABR] Waves

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04040517
• Other study ID #: 17100772
• Status: Not yet recruiting
• Start date: December 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: Mohamed Salama Bakr, MD
• Phone: 01006550289
• Email: mohamedsalamabakr[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

All children with hearing loss should have access to resources necessary to reach their maximum potential. The following principles provide the foundation for effective EHDI[Early Hearing Detection & Intervention] systems and have been updated and expanded since the 2000 JCIH [ joint Committee on Infant Hearing ] position statement .

Description:

1. All infants should have access to hearing screening using a physiologic measure at no later than 1 month of age.

2. All infants who do not pass the initial hearing screening and the subsequent rescreening should have appropriate audiological and medical evaluations to confirm the presence of hearing loss at no later than 3 months of age.

3. All infants with confirmed permanent hearing loss should receive early intervention services as soon as possible after diagnosis but at no later than 6 months of age. A simplified, single point of entry into an intervention system that is appropriate for children with hearing loss is optimal.

The importance of early identification and habilitation of hearing loss for improved access to auditory stimuli and for positive prognosis of speech and language is well established in the literature . Auditory brain stem response (ABR) is the most commonlly used test in clinical practice to estimate the degree of hearing loss, but the auditory brainstem response (ABR) cannot differentiate between severe and profound SNHL [5], whereas the ASSR can provide threshold information in a frequency-specific manner at intensity levels of 120 dB and higher. This intensity stimulation advantage uniquely qualifies the ASSR for investigation of residual hearing in young and difficult-to-test cochlear implant candidates.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Years

Eligibility

Inclusion Criteria:

• Absent ABR [Auditory Breanstem Response] waves .

• normal middle ear function

Exclusion Criteria:

• Ears with otitis media with effusion,

• Preserved otoacuastic emission ,

• Preserved ABR waves .

Related Conditions & MeSH terms

• Deafness
• Hearing Impaired Children
• Hearing Loss

Intervention

Diagnostic Test:
• Evoked potential audiometer
The ASSR [ steady state response] test stimuli are modulated pure tones with insert earphone..

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Wadhera R, Hernot S, Gulati SP, Kalra V. A controlled comparison of auditory steady-state responses and pure-tone audiometry in patients with hearing loss. Ear Nose Throat J. 2017 Oct-Nov;96(10-11):E47-E52. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A 40 hearing impaired children with absent ABR waves	evaluation by auditory steady state response (ASSR)	one year
Secondary	After ASSR evaluation for this patient we can take decision either for hearing aid amplification of for (surgery) cochlear implant .	evaluation by auditory steady state response (ASSR)	one year