Hearing Impaired ChildrenNCT04040517
Auditory Steady State Response vsAuditory Brainstem Response
An observational study of Hearing Impaired Children, run by Assiut University.
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 ]… Read more about this study
- Who is it for?
- Ages 1 day to 4 years
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- Evoked potential audiometer
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Jan 2021
- Phase
- Observational
- 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 1 day to 4 years
- All sexes
- No healthy volunteers
- Child
Study population: Evaluate of residual hearing function in hearing impaired children with absent ABR waves and normal middle ear pressure.
Who may be able to join
- Absent ABR [Auditory Breanstem Response] waves .
- normal middle ear function
Who cannot join
- Ears with otitis media with effusion,
- Preserved otoacuastic emission ,
- Preserved ABR waves .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: [ASSR] in Hearing Impaired Children With Absent [ABR] Waves
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 .
Read the detailed description
- All infants should have access to hearing screening using a physiologic measure at no later than 1 month of age.
- 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.
- 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.
- Conditions
- Hearing Impaired Children
- Being tested
- Evoked potential audiometer
- Keywords
- Hearing Loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evoked potential audiometerDiagnostic test
Also called Auditory steady state response
The ASSR [ steady state response] test stimuli are modulated pure tones with insert earphone..
What is being measured
The primary outcome is the main question the study is designed to answer.
A 40 hearing impaired children with absent ABR waves
evaluation by auditory steady state response (ASSR)
Measured: one year
Secondary outcomes (1)
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)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Galal Ibrahem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040517
- Sponsor's protocol ID
- 17100772
- Status last verified
- Jul 2019
- First submitted
- 21 May 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. doi: 10.1177/0145561317096010-1109.
PubMed 29121385
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [ASSR] in Hearing Impaired Children With Absent [ABR] Waves
- ClinicalTrials.gov ID
- NCT04040517
- Acronym / sponsor ID
- 17100772
- Conditions
- Hearing Impaired Children
- Keywords
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 31 Jul 2019 (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.
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 .
Detailed description
- All infants should have access to hearing screening using a physiologic measure at no later than 1 month of age.
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Evaluate of residual hearing function in hearing impaired children with absent ABR waves and normal middle ear pressure.
Key inclusion criteria (2 listed)
- Absent ABR [Auditory Breanstem Response] waves .
- normal middle ear function
Key exclusion criteria (3 listed)
- Ears with otitis media with effusion,
- Preserved otoacuastic emission ,
- Preserved ABR waves .
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 |
|---|---|---|
| Evoked potential audiometerAlso: Auditory steady state responseThe ASSR [ steady state response] test stimuli are modulated pure tones with insert earphone.. | Diagnostic test | – |
Primary outcome
A 40 hearing impaired children with absent ABR waves
Time frame: one year
evaluation by auditory steady state response (ASSR)
1 secondary outcome
After ASSR evaluation for this patient we can take decision either for hearing aid amplification of for (surgery) cochlear implant .
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Background: PubMed 29121385Wadhera 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. doi: 10.1177/0145561317096010-1109.
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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?
An observational study of 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 2 inclusion and 3 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 31 Jul 2019. 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 Mohamed Salama Bakr, MD (01006550289, mohamedsalamabakr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A 40 hearing impaired children with absent ABR waves (time frame: one year). 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 NCT04040517, which also lists 1 linked publication.
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 31 Jul 2019.