Long COVID-19 SyndromeNCT05670418
Cognitive Function Analysis and qEEG Study in Long COVID-19 Syndrome Patients
An observational study of Long COVID-19 Syndrome, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Over than 30% individuals with COVID-19, including the asymptomatic ones, and around 80% of patients hospitalized with COVID-19 may experience post-COVID sequelae, which is commonly referred to as Long COVID Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID-19 Syndrome
- What is being tested?
- Quantitative Electroencephalography
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2022to 30 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 Patients
Who may be able to join
- Post-COVID-19 patients with Long COVID-19 Syndrome
- Over 18 years old
- Willing to participate in the research
- Completed the Montreal Cognitive Assessment (MoCA) and Self Rating Questionnaire (SRQ)
Who cannot join
- 1. Patients with neuropsychiatric disorders before being infected with COVID-19
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Rumah Sakit Cipto Manunkusumo
Jakarta Pusat, DKI Jakarta, 10430
Yetty Ramli, MD, +62811163843, yettyramli@gmail.com
Yetty Ramli, MD
About this study
Over than 30% individuals with COVID-19, including the asymptomatic ones, and around 80% of patients hospitalized with COVID-19 may experience post-COVID sequelae, which is commonly referred to as Long COVID Syndrome. This condition has ties to decreased cognitive function and may lead to neuropsychiatric disorders but still need to be studied further. Using a cross-sectional design, this study will analyze the relationship between cognitive function and neuropsychiatric disorders with brain wave activity in Long COVID patients.
The investigators conducted assessments utilizing the quantitative electroencephalogram (qEEG) measurement method and interviews using instruments such as the MOCA questionnaire and Self Rating Questionnaire (SRQ). With this qEEG examination, the investigators hoped that there will be an imbalance/abnormality of brain wave activity that arises related to impaired cognitive function.
Read the detailed description
This study is aimed to analyze the cognitive function and neuropsychiatry disorders with brain wave activity using qEEG that occurs after COVID/Long Covid Syndrome.
The whole procedure will run for approximately 12 weeks based on the long COVID range.
The determinants of long COVID patients include: never been vaccinated, old age, comorbid, female population, and hospitalized patients.
The total number of subjects with the post-COVID syndrome in the proportion test is 30 subjects.
The measuring instruments used to measure the decline in cognitive function are the MOCA questionnaire and Self Rating Questionnaire (SRQ).
The target population is post-COVID-19 patients with Long COVID Syndrome.
The accessible population is post-COVID-19 patients who have been treated at RSCM Kiara and have regular checkups at the RSCM polyclinic with Long COVID Syndrome for 12 weeks or more.
The control population is post-COVID-19 patients who managed to recover without symptoms.
The Long COVID Syndrome patients who meet the inclusion criteria and have signed the consent.
- Conditions
- Long COVID-19 Syndrome
- Being tested
- Quantitative Electroencephalography
- Keywords
- Long COVID-19 Syndrome, COVID-19, Quantitative electroencephalography, Case-control study
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative ElectroencephalographyDevice
Each qEEG examination of one person lasted about 20 minutes and included two stages: the first-recording of brain waves with eyes closed (5 min), the other with eyes open (5 min)
| Study group | Role | What they receive |
|---|---|---|
| Long COVID-19 | Patients post-COVID-19 with Long COVID-19 Syndrome Receives: Device: Quantitative Electroencephalography | |
| COVID-19 | Patients post-COVID-19 without Long COVID-19 Syndrome Receives: Device: Quantitative Electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
Cognitive Function will be assessed using the qEEG, with an abnormality of brain wave activity, it indicates impairment of cognitive function
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Cognitive quality Assessed by MOCA
Severe score: ≤10 Moderate score: 10-17 Mild score: 18-25 Normal score: 26-30
Measured: Through study completion, an average of 1 year
Self Rating Questionnaire (SRQ)
Lowest score: 0 Highest score: 20. Higher score indicates better health status.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Oct 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr Yetty Ramli SpS, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670418
- Sponsor's protocol ID
- 22-05-0578
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function Analysis and qEEG Study in Long COVID-19 Syndrome Patients
- ClinicalTrials.gov ID
- NCT05670418
- Acronym / sponsor ID
- 22-05-0578
- Conditions
- Long COVID-19 Syndrome
- Keywords
- Long COVID-19 Syndrome, COVID-19, Quantitative electroencephalography, Case-control study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 4 Jan 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.
Over than 30% individuals with COVID-19, including the asymptomatic ones, and around 80% of patients hospitalized with COVID-19 may experience post-COVID sequelae, which is commonly referred to as Long COVID Syndrome. This condition has ties to decreased cognitive function and may lead to neuropsychiatric disorders but still need to be studied further. Using a cross-sectional design, this study will analyze the relationship between cognitive function and neuropsychiatric disorders with brain wave activity in Long COVID patients.
The investigators conducted assessments utilizing the quantitative electroencephalogram (qEEG) measurement method and interviews using instruments such as the MOCA questionnaire and Self Rating Questionnaire (SRQ). With this qEEG examination, the investigators hoped that there will be an imbalance/abnormality of brain wave activity that arises related to impaired cognitive function.
Detailed description
This study is aimed to analyze the cognitive function and neuropsychiatry disorders with brain wave activity using qEEG that occurs after COVID/Long Covid Syndrome.
The whole procedure will run for approximately 12 weeks based on the long COVID range.
The determinants of long COVID patients include: never been vaccinated, old age, comorbid, female population, and hospitalized patients.
The total number of subjects with the post-COVID syndrome in the proportion test is 30 subjects.
The measuring instruments used to measure the decline in cognitive function are the MOCA questionnaire and Self Rating Questionnaire (SRQ).
The target population is post-COVID-19 patients with Long COVID Syndrome.
The accessible population is post-COVID-19 patients who have been treated at RSCM Kiara and have regular checkups at the RSCM polyclinic with Long COVID Syndrome for 12 weeks or more.
The control population is post-COVID-19 patients who managed to recover without symptoms.
The Long COVID Syndrome patients who meet the inclusion criteria and have signed the consent.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long COVID-19 | – | Device: Quantitative ElectroencephalographyPatients post-COVID-19 with Long COVID-19 Syndrome |
| COVID-19 | – | Device: Quantitative ElectroencephalographyPatients post-COVID-19 without Long COVID-19 Syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 Patients
Key inclusion criteria (4 listed)
- Post-COVID-19 patients with Long COVID-19 Syndrome
- Over 18 years old
- Willing to participate in the research
- Completed the Montreal Cognitive Assessment (MoCA) and Self Rating Questionnaire (SRQ)
Key exclusion criteria (1 listed)
- 1. Patients with neuropsychiatric disorders before being infected with COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative ElectroencephalographyEach qEEG examination of one person lasted about 20 minutes and included two stages: the first-recording of brain waves with eyes closed (5 min), the other with eyes open (5 min) | Device | COVID-19, Long COVID-19 |
Primary outcome
Cognitive Function
Time frame: Through study completion, an average of 1 year
Cognitive Function will be assessed using the qEEG, with an abnormality of brain wave activity, it indicates impairment of cognitive function
2 secondary outcomes
Cognitive quality Assessed by MOCA
Time frame: Through study completion, an average of 1 year
Self Rating Questionnaire (SRQ)
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
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 Long COVID-19 Syndrome, run by Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Nov 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yetty Ramli, MD (+62811163843, yettyramli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: Through study completion, an average of 1 year). 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 18 Nov 2023.