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Completed

NCT Number: NCT05787301

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

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.

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Key information

Conditions

COVID-19 Cognition Disorders Cognitive Decline Cognitive Dysfunction Coronaviridae Infections Coronavirus Infections Ear Diseases Infections Lung Diseases Mental Disorders Neurocognitive Disorders Nidovirales Infections Otological Disease Otorhinolaryngologic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The correlation between the peak of COVID-19 transmission and the popularity of related online terms

    Time frame: through study completion, an average of 3 months

    The correlation between the peak of COVID-19 transmission and the popularity of related online terms

  2. Symptom incidence

    Time frame: 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.

  3. Pure tone average

    Time frame: 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.

  4. Mini-Mental State Examination score and grade

    Time frame: 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

  5. Montreal Cognitive Assessment score and grade

    Time frame: 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.

  6. Pittsburgh Sleep Quality Interview score and grade

    Time frame: 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

  7. Hamilton depression score and grade

    Time frame: 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.

  8. Resting state of Electroencephalogram data

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: COVID-19

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2023
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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