Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:09 AM
Study NCT ID:
NCT07447232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Ultrasonic and Conventional Spirometry in Chronic Respiratory Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement of FEV1 between Ultrasonic and Conventional Spirometers', 'timeFrame': 'one day', 'description': 'Agreement of forced expiratory volume in one second (FEV1) measured by the ultrasonic spirometer compared with the conventional spirometer, assessed using Bland-Altman analysis and correlation coefficients.'}], 'secondaryOutcomes': [{'measure': 'Test-Retest Reliability of Ultrasonic Spirometer (Reproducibility)', 'timeFrame': 'one day', 'description': 'Assessment of within-device repeatability of the ultrasonic spirometer across three forced expiratory maneuvers, evaluated by intraclass correlation coefficients (ICC) and coefficient of variation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease (COPD)', 'Spirometry', 'Ultrasonic Flow Sensor', 'Pulmonary Function Test'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)', 'Spirometry']}, 'descriptionModule': {'briefSummary': 'This study compares a handheld ultrasonic spirometer with a standard hospital spirometer in adults with chronic respiratory diseases. Each participant will complete lung function tests using both devices. The study aims to determine whether the ultrasonic device provides accurate and reliable measurements for use in clinical or home settings.', 'detailedDescription': 'This study aims to compare a new ultrasonic handheld spirometer with the standard hospital spirometer used in lung function testing. We want to find out whether the ultrasonic device can measure breathing strength and lung capacity as accurately and reliably as the traditional machine.\n\nAdults with chronic respiratory diseases-including COPD, asthma, bronchiectasis, and interstitial lung disease-will participate. Each participant will perform lung function tests using both devices in a randomized order. The results from the two methods will then be compared to see how closely they match.\n\nThe goal of this study is to determine whether the ultrasonic spirometer can be used as a convenient alternative tool for lung function monitoring in clinics, community settings, or at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 80 years.\n* Diagnosed with a chronic respiratory disease (e.g., COPD, asthma, bronchiectasis, or interstitial lung disease).\n* Willing to follow the instructions for using the ultrasonic spirometer.\n* Clinically stable and able to understand the study purpose and procedures, and who provide informed consent.\n\nExclusion Criteria:\n\n* Individuals who, after explanation, are still unable to properly perform the ultrasonic spirometry procedure.\n* Individuals who, after explanation, refuse to participate in the study.\n* Patients with unstable vital signs.\n* Pregnant or suspected pregnant women.'}, 'identificationModule': {'nctId': 'NCT07447232', 'briefTitle': 'Comparing Ultrasonic and Conventional Spirometry in Chronic Respiratory Disease', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University'}, 'officialTitle': 'A Comparative Study of Ultrasonic and Conventional Spirometers in Patients With Chronic Respiratory Diseases', 'orgStudyIdInfo': {'id': 'FJUH114492'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional Spirometer', 'description': 'Standard hospital spirometry performed according to ATS/ERS procedures to obtain FEV1, FVC, and PEF. In this study, spirometry is performed using the Conventional Spirometer first, followed by the Ultrasonic Spirometer.', 'interventionNames': ['Diagnostic Test: Spirometer']}, {'type': 'EXPERIMENTAL', 'label': 'Ultrasonic Spirometer', 'description': 'Standard hospital spirometry performed according to ATS/ERS procedures to obtain FEV1, FVC, and PEF. In this study, spirometry is performed using the Ultrasonic Spirometer first, followed by the Conventional Spirometer.', 'interventionNames': ['Diagnostic Test: Spirometer']}], 'interventions': [{'name': 'Spirometer', 'type': 'DIAGNOSTIC_TEST', 'description': 'The handheld ultrasonic spirometry device uses acoustic flow analysis to measure FEV1, FVC, and PEF and is evaluated for accuracy compared with the conventional spirometer. Participants may perform this test either before or after the conventional spirometry test, depending on the randomized crossover sequence.', 'armGroupLabels': ['Conventional Spirometer', 'Ultrasonic Spirometer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23148', 'city': 'New Taipei City', 'country': 'Taiwan', 'contacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': '148540@mail.fju.edu.tw', 'phone': '+886-905-301-879'}, {'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT'}], 'facility': 'Cardinal Tien Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': '148540@mail.fju.edu.tw', 'phone': '+886905301879'}], 'overallOfficials': [{'name': 'Ke-Yun Chao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fu Jen Catholic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Jen Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ke-Yun, Chao', 'investigatorAffiliation': 'Fu Jen Catholic University'}}}}