Qi-Xu; Qi DeficiencyNCT05739266
Pulmonary Function and Qi Deficiency Predicted by Acoustic Analysis
An observational study of Qi-Xu; Qi Deficiency and Pulmonary Function; COPD, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Acoustic analysis is a method of clinically non-invasive, low-cost, remote-operation, and can avoid direct face-to-face contact. It has been proved by many researches in recent years that it has a high diagnostic rate in predicting diseases. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Qi-Xu; Qi Deficiency, Pulmonary Function; COPD
- What is being tested?
- 3 minutes step test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2023to 30 Jun 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Students and staffs of China Medical University, Taiwan
Who may be able to join
- Age: over 20 years old.
- Agreed and signed Informed Consent Form.
Who cannot join
- Known heart diseases, acute severe respiratory infection, severe arthritis or other orthopedic disabilities, severe hypertension, or pregnant.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
No. 2, Yude Road, North District
Taichung, Taichung City, 404327
About this study
Official title: Prediction of Pulmonary Function and Qi Deficiency Based on the Acoustic Analysis Before and After Step Test
Acoustic analysis is a method of clinically non-invasive, low-cost, remote-operation, and can avoid direct face-to-face contact.
It has been proved by many researches in recent years that it has a high diagnostic rate in predicting diseases. Lung function is closely related to human vocalization and has the potential and need for sound analysis. From literature review, it can be inferred that the Qi deficiency constitution in TCM is related to the strength of heart and lung function.The purpose of this study is to investigate the correlation between cardiopulmonary function and Qi deficiency, and to predict the correlation between the data by computer algorithm and artificial intelligence. Furthermore, the artificial intelligence (AI) self-correction ability can be combined with sound analysis to simulate a sound analysis system that can predict cardiopulmonary function and degree of qi deficiency only through sound information.
Read more
Research motivation and questions:
- Is the sound characteristic of an individual related to individual's qi deficiency and cardiopulmonary function?
- Can lung function and qi deficiency be measured by sound analysis?
- To understand the correlation between Qi deficiency and cardiopulmonary endurance index.
- Is there any difference in sound characteristics before and after step test and does it help predicting cardiopulmonary function?
- Conditions
- Qi-Xu; Qi Deficiency, Pulmonary Function; COPD
- Being tested
- 3 minutes step test
- Keywords
- Qi-Xu; Qi deficiency, Pulmonary Function; COPD, Step test; heart recovery rate
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 minutes step testBehavioural
3 minutes step test- Stair hight:20 cm, Pace: 96 steps per minute
| Study group | Role | What they receive |
|---|---|---|
| Before step test | Before step test. -Participants record their before-step-test voice. | |
| After step test | After step test.
-Participants record their after-step-test voice. Receives: Behavioral: 3 minutes step test |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC<80%
FVC<80%
Measured: 10 mins
FVC>80%
FVC>80%
Measured: 10 mins
Qi deficient
Qi deficient
Measured: 10 mins
step test: heart rate recovery
Tecumseh step test.
Measured: 15 mins
Voice record
/a/, /e/, /i/, /o/, /u/, five seconds each, 3 times per person
Measured: 15 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Qi-Xu; Qi DeficiencyStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739266
- Sponsor's protocol ID
- CMUH111-REC2-036
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2023
- Last updated
- 22 Feb 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 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Pulmonary Function and Qi Deficiency Based on the Acoustic Analysis Before and After Step Test
- ClinicalTrials.gov ID
- NCT05739266
- Acronym / sponsor ID
- CMUH111-REC2-036
- Conditions
- Qi-Xu; Qi Deficiency, Pulmonary Function; COPD
- Keywords
- Qi-Xu; Qi deficiency, Pulmonary Function; COPD, Step test; heart recovery rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Feb 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.
Acoustic analysis is a method of clinically non-invasive, low-cost, remote-operation, and can avoid direct face-to-face contact.
It has been proved by many researches in recent years that it has a high diagnostic rate in predicting diseases. Lung function is closely related to human vocalization and has the potential and need for sound analysis. From literature review, it can be inferred that the Qi deficiency constitution in TCM is related to the strength of heart and lung function.The purpose of this study is to investigate the correlation between cardiopulmonary function and Qi deficiency, and to predict the correlation between the data by computer algorithm and artificial intelligence. Furthermore, the artificial intelligence (AI) self-correction ability can be combined with sound analysis to simulate a sound analysis system that can predict cardiopulmonary function and degree of qi deficiency only through sound information.
Research motivation and questions:
- Is the sound characteristic of an individual related to individual's qi deficiency and cardiopulmonary function?
- Can lung function and qi deficiency be measured by sound analysis?
- To understand the correlation between Qi deficiency and cardiopulmonary endurance index.
- Is there any difference in sound characteristics before and after step test and does it help predicting cardiopulmonary function?
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before step test | – | –Before step test. -Participants record their before-step-test voice. |
| After step test | – | Behavioral: 3 minutes step testAfter step test. -Participants record their after-step-test voice. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Students and staffs of China Medical University, Taiwan
Key inclusion criteria (2 listed)
- Age: over 20 years old.
- Agreed and signed Informed Consent Form.
Key exclusion criteria (1 listed)
- Known heart diseases, acute severe respiratory infection, severe arthritis or other orthopedic disabilities, severe hypertension, or pregnant.
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 |
|---|---|---|
| 3 minutes step test3 minutes step test- Stair hight:20 cm, Pace: 96 steps per minute | Behavioural | After step test |
Primary outcome
FVC<80%
Time frame: 10 mins
FVC<80%
FVC>80%
Time frame: 10 mins
FVC>80%
Qi deficient
Time frame: 10 mins
Qi deficient
step test: heart rate recovery
Time frame: 15 mins
Tecumseh step test.
Voice record
Time frame: 15 mins
/a/, /e/, /i/, /o/, /u/, five seconds each, 3 times per person
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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 Qi-Xu; Qi Deficiency and Pulmonary Function; COPD, run by China Medical University Hospital at 1 site in Taiwan.
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 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 22 Feb 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 Taiwan. 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 Jung- Nien Lai, MD(Doctor of medicine) (+886 910915762, ericlai111@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC<80% (time frame: 10 mins). The study lists 5 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 22 Feb 2023.