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

COVID-19 Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05787301
• Other study ID #: SYSKY-2023-151-01
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• COVID-19
• Ear Diseases

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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