NCT07199972

Brief Summary

COVID-19 is a respiratory disease caused by the coronavirus SARS-CoV-2, for which the first cases were reported in China, by December 2019. Previous studies reported cases of tinnitus following COVID infection, most of them mild and with similar characteristics to other forms of tinnitus. Our aim is to further explore the relationship between COVID-19 and tinnitus. For this purpose we analyzed people in the city of Volta Redonda, Brazil after a COVID-19 infection. In detail we compared those with new onset tinnitus during or after COVID-19 with those without tinnitus and those with tinnitus onset before the COVID-19 infection. Moreover we analyzed the prevalence of post-COVID tinnitus along the pandemic timeline, from 2020 to 2024.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
233

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration 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 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

September 28, 2025

Last Update Submit

September 28, 2025

Conditions

Hearing DisordersCOVID-19 Pandemic

Keywords

covid-19tinnitus

Outcome Measures

Primary Outcomes (1)

  • Trajectory of COVID-Related Tinnitus Over the Pandemic Timeline

    Post-COVID tinnitus x No tinnitus x chronic tinnitus

    February 2023 - November 2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had a previous COVID-19 infection

You may qualify if:

  • previous COVID-19 infection

You may not qualify if:

  • \< 18 yo
  • not willing to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OTOSUL, Otorrinolaringologia Sul-Fluminense

Volta Redonda, Rio de Janeiro, 27260-200, Brazil

Location

MeSH Terms

Conditions

Hearing DisordersCOVID-19Tinnitus

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Norma O Penido, MD,PhD

    Universidade Federal de São Paulo

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,MSc,PhD

Study Record Dates

First Submitted

September 28, 2025

First Posted

September 30, 2025

Study Start

February 1, 2023

Primary Completion

November 30, 2024

Study Completion

August 1, 2025

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations

BR(1)