Clinical trial NCT05862597: Post COVID-19 Syndrome Study With Questionnaires and Instruments Measurements
Official title: Post COVID-19 syndrome-the Correlation With Suboptimal Health Status and Its Changes of Pulse Diagnosis and Autonomic Nervous System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Detection
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
name: National Science and Technology Council
First posted: 2023-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have at least one symptom that cannot be explained by other diagnoses and lasts for at least 2 months after being infected with Covid-19.

Brief summary: COVID-19 has caused various long-term symptoms affecting different bodily functions. A study shows that traditional Chinese medicine can balance the human body disorder after a virus infection and restore health. The study proposes using pulse diagnosis and cardiac rhythm instruments for disease diagnosis and analysis, decomposing time domain pulse wave signals into different frequency ranges and calculating the "spectral energy ratio" and EP to quantify the patient's pathological pulse. The method has been applied to pulse wave analysis of people with suboptimal health status, and its effectiveness has been preliminarily confirmed. The study aims to find the relationship between these parameters and clinical subjective scale scores, to establish an objective data bridge for Chinese and Western medicine diagnosis. In the future, the analysis method will include more subject data to verify the completeness of the method and establish a feasible prediction model.

Detailed description: The coronavirus pneumonia (COVID-19) epidemic has a major global impact since 2019. So far, due to the continuous emergence of mutated strains of the virus, in addition to different clinical symptoms, the causes of disease and prognosis of infected patients are also different. With the rapid increase in the number of confirmed cases in Taiwan, we can see that there are many sequelae caused by the COVID-19. Although most of the infected patients can fully recover, some people have various medium and long-term symptoms, which are called "Long COVID or Post COVID". In addition to causing lung tissue damage and inflammation, the COVID-19 also affects the digestive system, causing patients to experience symptoms such as diarrhea, vomiting, and loss of appetite; damages the nervous system, causing insomnia, poor memory, and loss of taste and smell; affects the kidneys function and cause edema, etc.; or even reduce the number of sperm cells in men, thereby affecting reproductive function. It can be seen clinically that some symptoms will last for a long time or appear repeatedly. These symptoms may be present at the time of initial infection, may appear after recovery, or recur over time, affecting the patient's daily life. From our study, it reveals that through the conditioning diagnosis and treatment of traditional Chinese medicine, the human body disorder after virus infection can be balanced as soon as possible and the health can be restored.

This research proposes to use pulse diagnosis instrument and cardiac rhythm instrument for disease diagnosis and analysis, decompose time domain pulse wave signal into time domain signals of different frequency ranges, and extract 0-10Hz low frequency wave, 0-50Hz global wave, 13-50 Hz high-frequency waveform calculates the "spectral energy ratio (SER)" and EP to quantify the patient's pathological pulse. Try to find the relationship between this set of parameters and clinical subjective scale scores. The analysis method proposed in this study has been applied to the pulse wave analysis of people with suboptimal health status (SHS), and its effectiveness has been preliminarily confirmed. Corresponding relationship with heart rate variability (heart rate variability, HRV) high and low frequency parameters, to further link the activation status of sympathetic nerve and parasympathetic nerve, and establish an objective data bridge for Chinese and Western medicine diagnosis. In the future, more subject data will be included to verify the completeness of the analysis method and establish a feasible prediction model.

Eligibility criteria: Inclusion Criteria:

Adults the age between 20-70 years old with a history of Covid-19 infection,have been an interval of 3 months from the day when the rapid screening test was negative and have some unexplained symptom after being infected with Covid-19 and last for at least 2 months.

Exclusion Criteria:

1. Patient characteristics: have been diagnosed with Covid-19 within seven days, positive in the rapid test,pregnant women or take drugs that could easily affect the heart rate, such as β-Blocker, etc., or installed a pacemaker.
2. Disease characteristics: Subjects who have been diagnosis of mental illness by doctors,or diseases such as cancer that fall under the scope of major diseases covered by the national health insurance .

Primary outcomes:
measure: "Skylark" Pulse Analysis System
timeFrame: 6 sceond
Secondary outcomes:
measure: Post-Acute Covid-19 Syndrome questionnaires
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Center for Traditional Medicine, Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Yen-Ying KUNG, doctor
role: STUDY_DIRECTOR
References: