Hearing Loss, CochlearNCT06326866
Otoacoustic Emissions in Different Blood Types
An observational study of Hearing Loss, Cochlear, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study is to examine whether ABO and Rhesus (Rh) blood group systems have an association with distortion product otoacoustic emission (DPOAE) and transient otoacoustic emission (TEOAE) amplitudes with the hypothesis of blood groups may affect hearing thresholds. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Cochlear
- What is being tested?
- Otoacoustic emissions (non-invasive)
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2024to 18 Mar 2024
- 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 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals between the ages of 18-26 with known blood type without hearing loss
Who may be able to join
- not having hearing loss
- having a blood group card obtained from health institutions
Who cannot join
- not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association of Blood Type Differences and Signal-Noise Ratio in TEOAE and DPAOE in Individuals With Normal Hearing
The objective of this study is to examine whether ABO and Rhesus (Rh) blood group systems have an association with distortion product otoacoustic emission (DPOAE) and transient otoacoustic emission (TEOAE) amplitudes with the hypothesis of blood groups may affect hearing thresholds.
Read the detailed description
Many factors have a significant impact on otoacoustic emission (OAE) measurement and quality of analysis. Race, age and gender are among the non-pathological factors. To date there is clear data to demonstrate the association of blood types with OAEs. The aim of our research is to investigate the relation of different blood groups (ABO) and Rh factors on transient evoked OAE and distortion product OAE amplitudes and inner ear potentials, differences between ears and to contribute to the limited literature on cochlear hearing loss susceptibility and blood groups with the hypothesis that blood groups may be associated with hearing thresholds.
- Conditions
- Hearing Loss, Cochlear
- Being tested
- Otoacoustic emissions (non-invasive)
- Keywords
- otoacoustic emissions, blood type
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otoacoustic emissions (non-invasive)Diagnostic test
There is no invasive intervention in the study. Individuals with predetermined blood types will be included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with A Rh (+) blood group | Individuals with normal hearing and whose blood group was previously determined as A Rh (+) will be included and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. Receives: Diagnostic Test: Otoacoustic emissions (non-invasive) | |
| Individuals with A Rh (-) blood group | Individuals with normal hearing and whose blood group was previously determined as A Rh (-) will be included and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. Receives: Diagnostic Test: Otoacoustic emissions (non-invasive) | |
| Individuals with B Rh (+) blood group | Individuals with normal hearing and whose blood group was previously determined as B Rh (+) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. Receives: Diagnostic Test: Otoacoustic emissions (non-invasive) | |
| Individuals with B Rh (-) blood group | Individuals with normal hearing and whose blood group was previously determined as B Rh (-) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. Receives: Diagnostic Test: Otoacoustic emissions (non-invasive) | |
| Individuals with AB Rh (+) blood group | Individuals with normal hearing and whose blood group was previously determined as AB Rh (+) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. Receives: Diagnostic Test: Otoacoustic emissions (non-invasive) | |
| Individuals with AB Rh (-) blood group | Individuals with normal hearing and whose blood group was previously determined as AB Rh (-) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. Receives: Diagnostic Test: Otoacoustic emissions (non-invasive) | |
| Individuals with O Rh (+) blood group | Individuals with normal hearing and whose blood group was previously determined as O Rh (+) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. Receives: Diagnostic Test: Otoacoustic emissions (non-invasive) | |
| Individuals with O Rh (-) blood group | Individuals with normal hearing and whose blood group was previously determined as O Rh (-) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. Receives: Diagnostic Test: Otoacoustic emissions (non-invasive) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal to noise ratios
SNRs obtained for different frequencies in OAE In TEOAE, 1, 1.4, 2, 2.8, 4 kHz, in DPOAE 1, 1.4, 2, 2.8, 4, 6 kHz
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start7 Feb 2024
- Primary completion12 Mar 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, CochlearStudies of the same condition, open and under way.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyyup Kara, Istanbul University - Cerrahpasa
- Investigators
- Eyyup Kara, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326866
- Sponsor's protocol ID
- E-74555795-050.04-941208
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing is planned.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Blood Type Differences and Signal-Noise Ratio in TEOAE and DPAOE in Individuals With Normal Hearing
- ClinicalTrials.gov ID
- NCT06326866
- Acronym / sponsor ID
- E-74555795-050.04-941208
- Conditions
- Hearing Loss, Cochlear
- Keywords
- otoacoustic emissions, blood type
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 22 Mar 2024 (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.
The objective of this study is to examine whether ABO and Rhesus (Rh) blood group systems have an association with distortion product otoacoustic emission (DPOAE) and transient otoacoustic emission (TEOAE) amplitudes with the hypothesis of blood groups may affect hearing thresholds.
Detailed description
Many factors have a significant impact on otoacoustic emission (OAE) measurement and quality of analysis. Race, age and gender are among the non-pathological factors. To date there is clear data to demonstrate the association of blood types with OAEs. The aim of our research is to investigate the relation of different blood groups (ABO) and Rh factors on transient evoked OAE and distortion product OAE amplitudes and inner ear potentials, differences between ears and to contribute to the limited literature on cochlear hearing loss susceptibility and blood groups with the hypothesis that blood groups may be associated with hearing thresholds.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Individuals with A Rh (+) blood group | – | Diagnostic Test: Otoacoustic emissions (non-invasive)Individuals with normal hearing and whose blood group was previously determined as A Rh (+) will be included and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. |
| Individuals with A Rh (-) blood group | – | Diagnostic Test: Otoacoustic emissions (non-invasive)Individuals with normal hearing and whose blood group was previously determined as A Rh (-) will be included and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. |
| Individuals with B Rh (+) blood group | – | Diagnostic Test: Otoacoustic emissions (non-invasive)Individuals with normal hearing and whose blood group was previously determined as B Rh (+) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. |
| Individuals with B Rh (-) blood group | – | Diagnostic Test: Otoacoustic emissions (non-invasive)Individuals with normal hearing and whose blood group was previously determined as B Rh (-) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. |
| Individuals with AB Rh (+) blood group | – | Diagnostic Test: Otoacoustic emissions (non-invasive)Individuals with normal hearing and whose blood group was previously determined as AB Rh (+) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. |
| Individuals with AB Rh (-) blood group | – | Diagnostic Test: Otoacoustic emissions (non-invasive)Individuals with normal hearing and whose blood group was previously determined as AB Rh (-) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. |
| Individuals with O Rh (+) blood group | – | Diagnostic Test: Otoacoustic emissions (non-invasive)Individuals with normal hearing and whose blood group was previously determined as O Rh (+) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. |
| Individuals with O Rh (-) blood group | – | Diagnostic Test: Otoacoustic emissions (non-invasive)Individuals with normal hearing and whose blood group was previously determined as O Rh (-) will be included and and Transient evoked Otoacoustic Emissions (TOAE) and Distortion Product Otoacoustic Emissions (DPOAE) will be performed. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals between the ages of 18-26 with known blood type without hearing loss
Key inclusion criteria (2 listed)
- not having hearing loss
- having a blood group card obtained from health institutions
Key exclusion criteria (1 listed)
- not meeting inclusion criteria
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 |
|---|---|---|
| Otoacoustic emissions (non-invasive)There is no invasive intervention in the study. Individuals with predetermined blood types will be included in the study. | Diagnostic test | Individuals with A Rh (+) blood group, Individuals with A Rh (-) blood group, Individuals with AB Rh (+) blood group, Individuals with AB Rh (-) blood group, Individuals with B Rh (+) blood group, Individuals with B Rh (-) blood group, Individuals with O Rh (+) blood group, Individuals with O Rh (-) blood group |
Primary outcome
Signal to noise ratios
Time frame: 1 month
SNRs obtained for different frequencies in OAE In TEOAE, 1, 1.4, 2, 2.8, 4 kHz, in DPOAE 1, 1.4, 2, 2.8, 4, 6 kHz
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No. No data sharing is planned.
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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.
Eyyup Kara, PhD principal investigator
Istanbul University - Cerrahpasa
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 Hearing Loss, Cochlear, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 26 Mar 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal to noise ratios (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2024; AzTrials last refreshed its copy on 1 Nov 2026.