- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06326866
Otoacoustic Emissions in Different Blood Types
March 23, 2024 updated by: Eyyup Kara, Istanbul University - Cerrahpasa (IUC)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İstanbul, Turkey, 34107
- Eyyup KARA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Individuals between the ages of 18-26 with known blood type without hearing loss
Description
Inclusion Criteria:
- not having hearing loss
- having a blood group card obtained from health institutions
Exclusion Criteria:
- not meeting inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
There is no invasive intervention in the study.
Individuals with predetermined blood types will be included in the study.
|
|
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.
|
There is no invasive intervention in the study.
Individuals with predetermined blood types will be included in the study.
|
|
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.
|
There is no invasive intervention in the study.
Individuals with predetermined blood types will be included in the study.
|
|
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.
|
There is no invasive intervention in the study.
Individuals with predetermined blood types will be included in the study.
|
|
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.
|
There is no invasive intervention in the study.
Individuals with predetermined blood types will be included in the study.
|
|
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.
|
There is no invasive intervention in the study.
Individuals with predetermined blood types will be included in the study.
|
|
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.
|
There is no invasive intervention in the study.
Individuals with predetermined blood types will be included in the study.
|
|
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.
|
There is no invasive intervention in the study.
Individuals with predetermined blood types will be included in the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eyyup Kara, PhD, Istanbul University - Cerrahpasa (IUC)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2024
Primary Completion (Actual)
March 12, 2024
Study Completion (Actual)
March 18, 2024
Study Registration Dates
First Submitted
March 18, 2024
First Submitted That Met QC Criteria
March 18, 2024
First Posted (Actual)
March 22, 2024
Study Record Updates
Last Update Posted (Actual)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 23, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-74555795-050.04-941208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No data sharing is planned.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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