NCT06326866

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

March 18, 2024

Last Update Submit

March 23, 2024

Conditions

Keywords

otoacoustic emissionsblood type

Outcome Measures

Primary Outcomes (1)

  • 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

    1 month

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Diagnostic Test: Otoacoustic emissions (non-invasive)

Interventions

There is no invasive intervention in the study. Individuals with predetermined blood types will be included in the study.

Individuals with A Rh (+) blood groupIndividuals with A Rh (-) blood groupIndividuals with AB Rh (+) blood groupIndividuals with AB Rh (-) blood groupIndividuals with B Rh (+) blood groupIndividuals with B Rh (-) blood groupIndividuals with O Rh (+) blood groupIndividuals with O Rh (-) blood group

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals between the ages of 18-26 with known blood type without hearing loss

You may qualify if:

  • not having hearing loss
  • having a blood group card obtained from health institutions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eyyup KARA

Istanbul, 34107, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Otoacoustic Emissions, Spontaneous

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HearingVestibulocochlear Physiological PhenomenaPhysiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eyyup Kara, PhD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 22, 2024

Study Start

February 7, 2024

Primary Completion

March 12, 2024

Study Completion

March 18, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

No data sharing is planned.

Locations