COVID-19COVID-19NCT05787301
Study of Epidemiologic Investigation and Mechanism of Brain Network of Otologic and Cognitive Function With Post-COVID-19
An observational study of COVID-19 and Cognitive Decline, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Cognitive Decline, Otological Disease
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A total of 748 patients with novel coronavirus were surveyed from December 2022 to February 2023.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
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
- Medical subject headings
- COVID-19, Cognitive Dysfunction, Ear Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Dec 2022
- Primary completion28 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787301
- Sponsor's protocol ID
- SYSKY-2023-151-01
- Acronym
- COVID-19
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Epidemiologic Investigation and Mechanism of Brain Network of Otologic and Cognitive Function With Post-COVID-19
- ClinicalTrials.gov ID
- NCT05787301
- Acronym / sponsor ID
- COVID-19 / SYSKY-2023-151-01
- Conditions
- COVID-19, Cognitive Decline, Otological Disease
- Keywords
- COVID-19, Epidemiologic Investigation, Brain network, Otological Symptoms, Cognitive Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 748 patients with novel coronavirus were surveyed from December 2022 to February 2023.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Cognitive Decline, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.