Study of Epidemiologic Investigation and Mechanism of Brain Network of Otologic and Cognitive Function With Post-COVID-19 (COVID-19)

March 26, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The purpose of this study was to analysis the incidence of ear symptoms, cognitive function decline and emotional disorders in Chinese people who were infected with COVID-19, exploring the impact of COVID-19 on the auditory system, cognitive function and emotional function, and analyzing the changes in functional connectivity of brain network after COVID-19 infection.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A total of 748 patients with novel coronavirus were surveyed from December 2022 to February 2023.

Description

Inclusion Criteria:

  • Confirmed cases of COVID-19 that test positive for nucleic acid or antigen
  • After infection with COVID-19, the patient has experienced hearing loss, tinnitus, ear tightness, ear pain, vertigo and other ear symptoms, memory loss, depression and so on

Exclusion Criteria:

  • Diagnosed cognitive disability
  • Patients with confirmed Meniere's disease, auditory neuropathy, and heavy noise exposure
  • Those with incomplete basic information or for other reasons are unable to complete questionnaires and other listening and cognitive assessments

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
Patients with hearing loss after infection
Patients with hearing loss before infection
Healthy control
Healthy subjects who have never been infected with COVID-19 or diagnosed with hearing loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between the peak of COVID-19 transmission and the popularity of related online terms
Time Frame: through study completion, an average of 3 months
The correlation between the peak of COVID-19 transmission and the popularity of related online terms
through study completion, an average of 3 months
Symptom incidence
Time Frame: through study completion, an average of 3 months
According to the questionnaire survey of 748 patients, the incidence of hearing loss, tinnitus, ear tightness, earache, vertigo or other cognitive and emotional problems after COVID-19 was analyzed.
through study completion, an average of 3 months
Pure tone average
Time Frame: through study completion, an average of 3 months
According to the WHO grading standard of hearing loss in 1980, the average pure tone threshold (PTA) of 0.5k, 1k, 2k and 4kHz in better ears was defined as normal hearing, 26-40 dB HL(hearing level) was defined as mild hearing loss, and 41-55 dB HL was defined as moderate hearing loss. 56-70 dB HL was moderate to severe hearing loss, 71-90 dB HL was severe hearing loss, and ≥91 dB HL was extremely severe hearing loss.
through study completion, an average of 3 months
Mini-Mental State Examination score and grade
Time Frame: through study completion, an average of 3 months
There are 30 points in the Mini-Mental State Examination (MMSE) scale. The score of 27-30 is normal, and 21-26 is mild dementia. 10-20 is moderate dementia; On a scale of 0 to 9, dementia is severe
through study completion, an average of 3 months
Montreal Cognitive Assessment score and grade
Time Frame: through study completion, an average of 3 months
The total score of the Montreal Cognitive Assessment (MoCA) scale is 30 points, generally ≥26 points normal, 18-26 points mild cognitive impairment, 10-17 points moderate cognitive impairment, and < 10 points severe cognitive impairment.
through study completion, an average of 3 months
Pittsburgh Sleep Quality Interview score and grade
Time Frame: through study completion, an average of 3 months
Pittsburgh Sleep Quality Index (PSQI) Scale total scores 21 points. A score of 0-5 indicates good sleep quality; A score of 6-10 indicates good sleep quality; 11-15 points, indicating average sleep quality; A score of 16 to 21 indicates poor sleep quality
through study completion, an average of 3 months
Hamilton depression score and grade
Time Frame: through study completion, an average of 3 months
For the 24th version of Hamilton depression Scale (HAMD), the total score > 35 May indicate severe depression; 21-35, may be mild to moderate depression; 9-20, suspected depression; < 8 indicates normal.
through study completion, an average of 3 months
Resting state of Electroencephalogram data
Time Frame: through study completion, an average of 3 months
Electroencephalogram (EEG) data of the study were preprocessed and trends in functional brain network connectivity were analyzed.
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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)

December 1, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 26, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 26, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2023-151-01

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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