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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05787301
Acronym
COVID-19
Enrollment
30
Registered
2023-03-28
Start date
2022-12-01
Completion date
2023-03-01
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, COVID-19, Otological Disease

Keywords

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

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.

Interventions

None listed

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
The correlation between the peak of COVID-19 transmission and the popularity of related online termsthrough study completion, an average of 3 monthsThe correlation between the peak of COVID-19 transmission and the popularity of related online terms
Symptom incidencethrough study completion, an average of 3 monthsAccording 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 averagethrough study completion, an average of 3 monthsAccording 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 gradethrough study completion, an average of 3 monthsThere 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 gradethrough study completion, an average of 3 monthsThe 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 gradethrough study completion, an average of 3 monthsPittsburgh 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 gradethrough study completion, an average of 3 monthsFor 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 datathrough study completion, an average of 3 monthsElectroencephalogram (EEG) data of the study were preprocessed and trends in functional brain network connectivity were analyzed.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026