- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07254442
Investigation of the Impact of Medications Used in COVID-19 Treatment and COVID-19 Vaccine on Hearing
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Biruni University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Those who have had COVID-19 and are taking medication
- Those who have had COVID-19 and are not taking medication
- Healthy individuals who have not had COVID-19
Description
Inclusion Criteria:
Age between 18 and 35 For the Medication group: Having had COVID-19 and using COVID-19 medications For the Non-Medication group: Having had COVID-19 and not using COVID-19 medications For the Control group: Having never had COVID-19
Exclusion Criteria:
Previously diagnosed with hearing loss Use of ototoxic medications other than those specified Pathology detected during tympanometric evaluation or otoscopic examination Chronic disease Family history of hearing loss History of meningitis Neurological disorders Acute or chronic ear infection Admission to intensive care
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control group
Group that has not had Covid-19
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Participants' pure tone thresholds, high frequency thresholds, and otoacoustic emissions measurements were evaluated.
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Medication Group
The group that had Covid-19 and used medication
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Participants' pure tone thresholds, high frequency thresholds, and otoacoustic emissions measurements were evaluated.
|
|
Non-medication group
The group that had Covid-19 and did not use medication
|
Participants' pure tone thresholds, high frequency thresholds, and otoacoustic emissions measurements were evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pure tone and high frequency hearing thresholds
Time Frame: December, 2021-February 2022
|
December, 2021-February 2022
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Transient evoked otoacoustic emissions - Signal/noise ratio
Time Frame: December, 2021-February 2022
|
December, 2021-February 2022
|
|
Distortion product otoacoustic emissions- signal/noise ratio
Time Frame: December, 2021-February 2022
|
December, 2021-February 2022
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Pathologic Processes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Chemically-Induced Disorders
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Otorhinolaryngologic Diseases
- Ear Diseases
- Drug-Related Side Effects and Adverse Reactions
- Radiation Injuries
- Pathological Conditions, Signs and Symptoms
- COVID-19
- Ototoxicity
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Otological
- Hearing Tests
Other Study ID Numbers
- 2021/61-18
- 1919B012102481 (Other Grant/Funding Number: TUBİTAK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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