Pulmonary Function and Qi Deficiency Predicted by Acoustic Analysis

• Sponsor: China Medical University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05739266
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 4.4
• Patients Per Site Per Month: 22.5

Study Details

Study Description

Brief 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. 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:

1. Is the sound characteristic of an individual related to individual's qi deficiency and cardiopulmonary function?

2. Can lung function and qi deficiency be measured by sound analysis?

3. To understand the correlation between Qi deficiency and cardiopulmonary endurance index.

4. Is there any difference in sound characteristics before and after step test and does it help predicting cardiopulmonary function?

Condition or Disease	Intervention/Treatment	Phase
Qi-Xu; Qi Deficiency; Pulmonary Function; COPD	Behavioral: 3 minutes step test

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Crossover
• Time Perspective: Cross-Sectional
• Official Title: Prediction of Pulmonary Function and Qi Deficiency Based on the Acoustic Analysis Before and After Step Test
• Anticipated Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: 3 minutes step test; 3 minutes step test- Stair hight:20 cm, Pace: 96 steps per minute

Outcome Measures

Primary Outcome Measures

1. FVC<80% [10 mins]

   FVC<80%

2. FVC>80% [10 mins]

   FVC>80%

3. Qi deficient [10 mins]

   Qi deficient

4. step test: heart rate recovery [15 mins]

   Tecumseh step test.

5. Voice record [15 mins]

   /a/, /e/, /i/, /o/, /u/, five seconds each, 3 times per person

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age: over 20 years old.

• Agreed and signed Informed Consent Form.

Exclusion Criteria:

• Known heart diseases, acute severe respiratory infection, severe arthritis or other orthopedic disabilities, severe hypertension, or pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	No. 2, Yude Road, North District	Taichung	Taichung City	Taiwan	404327

Sponsors and Collaborators

• China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT05739266
• Other Study ID Numbers: CMUH111-REC2-036
• First Posted: Feb 22, 2023
• Last Update Posted: Feb 22, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by China Medical University Hospital: Qi-Xu; Qi deficiency; Pulmonary Function; COPD; Step test; heart recovery rate

Study Results

No Results Posted as of Feb 22, 2023