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CompletedNCT05787301COVID-19Updated Mar 28, 2023

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

An observational study in COVID-19, Cognitive Decline and Otological Disease, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Sex
All
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Study summary

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.

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Conditions studied

  • COVID-19
  • Cognitive Decline
  • Otological Disease

Keywords

  • COVID-19
  • Epidemiologic Investigation
  • Brain network
  • Otological Symptoms
  • Cognitive Function
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 30 is below the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with hearing loss after infection

    Patients with hearing loss after infection

  • Patients with hearing loss before infection

    Patients with hearing loss before infection

  • Healthy control

    Healthy subjects who have never been infected with COVID-19 or diagnosed with hearing loss.

06

What researchers measure

Primary outcomes

  1. The correlation between the peak of COVID-19 transmission and the popularity of related online terms

    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

  2. Symptom incidence

    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.

    Time frame: through study completion, an average of 3 months

  3. Pure tone average

    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.

    Time frame: through study completion, an average of 3 months

  4. Mini-Mental State Examination score and grade

    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

    Time frame: through study completion, an average of 3 months

  5. Montreal Cognitive Assessment score and grade

    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.

    Time frame: through study completion, an average of 3 months

  6. Pittsburgh Sleep Quality Interview score and grade

    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

    Time frame: through study completion, an average of 3 months

  7. Hamilton depression score and grade

    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.

    Time frame: through study completion, an average of 3 months

  8. Resting state of Electroencephalogram data

    Electroencephalogram (EEG) data of the study were preprocessed and trends in functional brain network connectivity were analyzed.

    Time frame: through study completion, an average of 3 months

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05787301
Responsible party
Sponsor
First posted
Mar 28, 2023
Start date
Dec 1, 2022
Primary completion
Feb 28, 2023
Completion
Mar 1, 2023
Last update
Mar 28, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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