Study of Epidemiologic Investigation and Mechanism of Brain Network of Otologic and Cognitive Function With Post-COVID-19
- Conditions
- Cognitive DeclineCOVID-19Otological Disease
- Registration Number
- NCT05787301
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
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
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.
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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China