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

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Completed

CT.gov ID

NCT05787301

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Cognitive Decline Otological Disease

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2022

Actual Primary Completion Date :

Feb 28, 2023

Actual Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

The correlation between the peak of COVID-19 transmission and the popularity of related online terms [through study completion, an average of 3 months]
The correlation between the peak of COVID-19 transmission and the popularity of related online terms
Symptom incidence [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.
Pure tone average [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.
Mini-Mental State Examination score and grade [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
Montreal Cognitive Assessment score and grade [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.
Pittsburgh Sleep Quality Interview score and grade [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
Hamilton depression score and grade [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.
Resting state of Electroencephalogram data [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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