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

NCT05787301 | Completed

• 1 other identifier: SYSKY-2023-151-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Cognitive Decline; Otological Disease

Keywords

COVID-19; Epidemiologic Investigation; Brain network; Otological Symptoms; Cognitive Function

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

COVID-19; Cognitive Dysfunction; Ear Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: March 28, 2023
• Study Start: December 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 1, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

CN (1)