Asymmetrical Hearing LossNCT05543135
Aetiology of Asymmetrical Hearing Loss: A Retro-spective Study Thesis Submitted for Partial Fulfillment of Master Degree in Audio-Vestibular Medicine
An observational study of Asymmetrical Hearing Loss, run by Sohag University at 1 site in Egypt.
Trial summary
Hearing loss maybe: -Symmetrical: in which the severity and pattern of hearing loss are the same in each ear. Or -Asymmetrical: is defined as binaural difference in bone conduction thresholds of >10 dB at two consecutive frequencies or >20 dB at one frequency (0.25-8.0 kHz), Poorer speech perception will often… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Asymmetrical Hearing Loss
- What is being tested?
- basic audiological evaluation
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2022to Sep 2023
- 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 6 years and older
- All sexes
- Child, Adult, Older adult
Study population: all patients with asymmetrical hearing loss with age ranging 6 years old and more.
Who may be able to join
- Age: 6 years old and more.
- Sex: male and female.
Who cannot join
- Age: less than 6 years old.
- Patients with symmetrical hearing loss.
Trial locations and contacts
1 site in 1 country.
Mohamed A Abdelrahman, professor contact
About this study
Hearing loss maybe: -Symmetrical: in which the severity and pattern of hearing loss are the same in each ear. Or -Asymmetrical: is defined as binaural difference in bone conduction thresholds of >10 dB at two consecutive frequencies or >20 dB at one frequency (0.25-8.0 kHz), Poorer speech perception will often accompany poorer hearing and may be the reason for the patient's presentation .Unilateral or asymmetrical sensorineural hearing loss is important to discern, as it is an important risk factor for auditory nerve tumors (i.e. vestibular schwannoma) which is a life threatening condition, and in such cases further investigation is required (i.e. MRI scan) unless there is a known reason for the asymmetry, Several reports have recommended that further evaluation, especially expensive imaging studies, be conducted to rule out acoustic tumors when AHL is present
- Conditions
- Asymmetrical Hearing Loss
- Being tested
- basic audiological evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basic audiological evaluationDiagnostic test
Also called CT&MRI
pure tone audiometry\&immitancemetry
| Study group | Role | What they receive |
|---|---|---|
| cases | patients with asymmetrical hearing loss Receives: Diagnostic Test: basic audiological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymmetrical hearing loss
asymmetrical hearing loss using basic audiological evalution \&imaging
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start20 Sep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Asymmetrical Hearing LossStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inas Mahmoud Mahrous, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543135
- Sponsor's protocol ID
- Soh-Med-22-07-09
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dunn CC, Tyler RS, Oakley S, Gantz BJ, Noble W. Comparison of speech recognition and localization performance in bilateral and unilateral cochlear implant users matched on duration of deafness and age at implantation. Ear Hear. 2008 Jun;29(3):352-9. doi: 10.1097/AUD.0b013e318167b870.
PubMed 18453885Margolis RH, Saly GL. Asymmetric hearing loss: definition, validation, and prevalence. Otol Neurotol. 2008 Jun;29(4):422-31. doi: 10.1097/MAO.0b013e31816c7c09.
PubMed 18418281Peng AW, Salles FT, Pan B, Ricci AJ. Integrating the biophysical and molecular mechanisms of auditory hair cell mechanotransduction. Nat Commun. 2011 Nov 1;2:523. doi: 10.1038/ncomms1533.
PubMed 22045002Plack CJ, Barker D, Hall DA. Pitch coding and pitch processing in the human brain. Hear Res. 2014 Jan;307:53-64. doi: 10.1016/j.heares.2013.07.020. Epub 2013 Aug 11.
PubMed 23938209
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aetiology of Asymmetrical Hearing Loss: A Retro-spective Study Thesis Submitted for Partial Fulfillment of Master Degree in Audio-Vestibular Medicine
- ClinicalTrials.gov ID
- NCT05543135
- Acronym / sponsor ID
- Soh-Med-22-07-09
- Conditions
- Asymmetrical Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 16 Sep 2022 (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.
Hearing loss maybe: -Symmetrical: in which the severity and pattern of hearing loss are the same in each ear. Or -Asymmetrical: is defined as binaural difference in bone conduction thresholds of >10 dB at two consecutive frequencies or >20 dB at one frequency (0.25-8.0 kHz), Poorer speech perception will often accompany poorer hearing and may be the reason for the patient's presentation .Unilateral or asymmetrical sensorineural hearing loss is important to discern, as it is an important risk factor for auditory nerve tumors (i.e. vestibular schwannoma) which is a life threatening condition, and in such cases further investigation is required (i.e. MRI scan) unless there is a known reason for the asymmetry, Several reports have recommended that further evaluation, especially expensive imaging studies, be conducted to rule out acoustic tumors when AHL is present
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases | – | Diagnostic Test: basic audiological evaluationpatients with asymmetrical hearing loss |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with asymmetrical hearing loss with age ranging 6 years old and more.
Key inclusion criteria (2 listed)
- Age: 6 years old and more.
- Sex: male and female.
Key exclusion criteria (2 listed)
- Age: less than 6 years old.
- Patients with symmetrical hearing loss.
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 |
|---|---|---|
| basic audiological evaluationAlso: CT&MRIpure tone audiometry\&immitancemetry | Diagnostic test | cases |
Primary outcome
Asymmetrical hearing loss
Time frame: 1 year
asymmetrical hearing loss using basic audiological evalution \&imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Background: PubMed 18453885Dunn CC, Tyler RS, Oakley S, Gantz BJ, Noble W. Comparison of speech recognition and localization performance in bilateral and unilateral cochlear implant users matched on duration of deafness and age at implantation. Ear Hear. 2008 Jun;29(3):352-9. doi: 10.1097/AUD.0b013e318167b870.
- Background: PubMed 18418281Margolis RH, Saly GL. Asymmetric hearing loss: definition, validation, and prevalence. Otol Neurotol. 2008 Jun;29(4):422-31. doi: 10.1097/MAO.0b013e31816c7c09.
- Background: PubMed 22045002Peng AW, Salles FT, Pan B, Ricci AJ. Integrating the biophysical and molecular mechanisms of auditory hair cell mechanotransduction. Nat Commun. 2011 Nov 1;2:523. doi: 10.1038/ncomms1533.
- Background: PubMed 23938209Plack CJ, Barker D, Hall DA. Pitch coding and pitch processing in the human brain. Hear Res. 2014 Jan;307:53-64. doi: 10.1016/j.heares.2013.07.020. Epub 2013 Aug 11.
- Individual participant dataSharing planned: Undecided
Related trials for Asymmetrical Hearing Loss
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
Recruiting
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Unilateral Hearing Loss, Asymmetric Hearing Loss
Active, not recruiting
Single-Sided Deafness and Asymmetric Hearing Loss
Hearing Loss, Unilateral, Hearing Loss, Sensorineural
Recruiting
Optimization of Hearing Performance in the Subject Implanted
Hearing Loss
Enrolling by invitation
Impact of Anatomy-Based Cochlear Implant Programming on Early Performance
Hearing Loss, Unilateral, Cochlear Implants
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.
Mohamed A Abdelrahman, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asymmetrical Hearing Loss, run by Sohag University at 1 site in Egypt.
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 2 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 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Enas M Mahrous, resident doctor (01096769904, inas_mahmoud_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asymmetrical hearing loss (time frame: 1 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 NCT05543135, which also lists 4 linked publications.
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 16 Sep 2022.