Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-01-05 @ 1:38 PM
Study NCT ID:
NCT05739266
Status:
UNKNOWN
Last Update Posted:
2023-02-22
First Post:
2023-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Function and Qi Deficiency Predicted by Acoustic Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-12', 'studyFirstSubmitDate': '2023-02-12', 'studyFirstSubmitQcDate': '2023-02-12', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FVC<80%', 'timeFrame': '10 mins', 'description': 'FVC\\<80%'}, {'measure': 'FVC>80%', 'timeFrame': '10 mins', 'description': 'FVC\\>80%'}, {'measure': 'Qi deficient', 'timeFrame': '10 mins', 'description': 'Qi deficient'}, {'measure': 'step test: heart rate recovery', 'timeFrame': '15 mins', 'description': 'Tecumseh step test.'}, {'measure': 'Voice record', 'timeFrame': '15 mins', 'description': '/a/, /e/, /i/, /o/, /u/, five seconds each, 3 times per person'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Qi-Xu; Qi deficiency', 'Pulmonary Function; COPD', 'Step test; heart recovery rate'], 'conditions': ['Qi-Xu; Qi Deficiency', 'Pulmonary Function; COPD']}, 'descriptionModule': {'briefSummary': "Acoustic analysis is a method of clinically non-invasive, low-cost, remote-operation, and can avoid direct face-to-face contact.\n\nIt 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.\n\nResearch motivation and questions:\n\n1. Is the sound characteristic of an individual related to individual's qi deficiency and cardiopulmonary function?\n2. Can lung function and qi deficiency be measured by sound analysis?\n3. To understand the correlation between Qi deficiency and cardiopulmonary endurance index.\n4. Is there any difference in sound characteristics before and after step test and does it help predicting cardiopulmonary function?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Students and staffs of China Medical University, Taiwan', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: over 20 years old.\n* Agreed and signed Informed Consent Form.\n\nExclusion Criteria:\n\n* Known heart diseases, acute severe respiratory infection, severe arthritis or other orthopedic disabilities, severe hypertension, or pregnant.'}, 'identificationModule': {'nctId': 'NCT05739266', 'briefTitle': 'Pulmonary Function and Qi Deficiency Predicted by Acoustic Analysis', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Prediction of Pulmonary Function and Qi Deficiency Based on the Acoustic Analysis Before and After Step Test', 'orgStudyIdInfo': {'id': 'CMUH111-REC2-036'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before step test', 'description': 'Before step test.\n\n-Participants record their before-step-test voice.'}, {'label': 'After step test', 'description': 'After step test.\n\n-Participants record their after-step-test voice.', 'interventionNames': ['Behavioral: 3 minutes step test']}], 'interventions': [{'name': '3 minutes step test', 'type': 'BEHAVIORAL', 'description': '3 minutes step test- Stair hight:20 cm, Pace: 96 steps per minute', 'armGroupLabels': ['After step test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404327', 'city': 'Taichung', 'state': 'Taichung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'No. 2, Yude Road, North District', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Jung- Nien Lai, MD(Doctor of medicine)', 'role': 'CONTACT', 'email': 'ericlai111@gmail.com', 'phone': '+886 910915762'}, {'name': 'Sophie Juang, TCM undergraduate', 'role': 'CONTACT', 'email': 'u108030090@cmu.edu.tw', 'phone': '+886 919530929'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}