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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19, Cognitive Decline, Otological Disease

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with hearing loss after infection<br>Patients with hearing loss after infection | |
| Patients with hearing loss before infection<br>Patients with hearing loss before infection | |
| Healthy control<br>Healthy subjects who have never been infected with COVID-19 or diagnosed with hearing loss. | |

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Epidemiologic Investigation, Brain network, Otological Symptoms, Cognitive Function