Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:47 AM
Study NCT ID:
NCT07440420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an AR-Assisted System for Standardizing Spirometry
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 710}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The consistency of quality grades distribution', 'timeFrame': 'At the completion of the spirometry session (Day 1)', 'description': 'The primary outcome in Phase 1 is the consistency of spirometry quality grades distribution (A-F) between AR-assisted and senior technician-led guidance mode. The quality grade serves as the critical metric for determining the clinical reliability of spirometry results. Variables of good quality are those of grades A and B, of sufficient quality are those of grade C, and variables of grades D and lower are not useful for interpretation.'}, {'measure': 'Number of attempts for a successful spirometry examination', 'timeFrame': 'At the completion of the spirometry session (Day 1)', 'description': 'This study defines a successful examination as achieving a quality grade of B or higher. The primary outcome in Phase 2 is the number of attempts required to complete a successful examination.'}], 'secondaryOutcomes': [{'measure': 'Examination time (phase 2)', 'timeFrame': 'At the completion of the spirometry session (Day 1)', 'description': 'The total duration from the initial instruction to the conclusion of the final maneuver.'}, {'measure': 'Success rate (phase 2)', 'timeFrame': 'Through trial completion, an average of 2 months', 'description': 'The proportion of participants achieving a successful examination in the Intention-to-Treat (ITT) population.'}, {'measure': 'Participant satisfaction (phase 2)', 'timeFrame': 'Immediately post-test', 'description': 'It reflect the comfort and clarity of the instructions provided, assessed via a 5-point Likert scale. The scale ranges from 1 to 5, with higher scores representing better comfort and clearer instructions.'}, {'measure': 'Incremental Cost-Effectiveness Ratio (phase 2)', 'timeFrame': 'At enrollment', 'description': 'The ratio of the difference in mean total medical costs to the difference in success rates between the intervention and control groups. The medical costs include direct and indirect costs. Data for indirect costs, including transportation expenses and productivity loss estimated based on wages and work time loss, will be collected via an economic questionnaire at enrollment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Augmented Reality', 'Spirometry', 'Chronic Obstructive Pulmonary Disease', 'Primary Health Care', 'Digital Health', 'Study Protocol'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Spirometry is the gold-standard tool for diagnosing Chronic Obstructive Pulmonary Disease (COPD). However, its implementation in primary care is often limited by a shortage of qualified technicians and inconsistent testing quality. This study will use Augmented Reality (AR) glasses to provide real-time interaction and guidance to participants during spirometry. It will be designed as a two-phase study to evaluate the technical validity and clinical effectiveness of AR-assisted spirometry (AR-SPIRO) system.', 'detailedDescription': 'The AR-SPIRO system includes a portable spirometer, an iPad for data processing, and AR glasses for visual and voice instructions. In phase 1, 60 participants will undergo spirometry under two guidance modes (AR-assisted guidance and senior technician-led guidance) at the China-Japan Friendship Hospital. Researchers will compare the quality grades from both methods. If the agreement score (Kappa) is 0.7 or higher, the study will move to the phase 2. In phase 2, 650 people will participate at 14 primary care medical institutions. They will be randomly assigned in a 1:1 ratio to either the intervention (AR-assisted guidance) or the control group (routine guidance by primary-care technicians).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPhase 1\n\n* Age ≥ 18 years.\n* Able to provide written informed consent.\n\nPhase 2\n\n* Age ≥ 40 years.\n* Cumulative smoking history of ≥10 pack-years or history of biomass fuel exposure for ≥10 years.\n* Able to provide written informed consent.\n\nExclusion Criteria (both two phase):\n\n* Presence of absolute or relative contraindications to spirometry.\n* Current pregnancy.\n* Severe vision or hearing impairments that preclude the effective use of Augmented Reality (AR) glasses.'}, 'identificationModule': {'nctId': 'NCT07440420', 'briefTitle': 'Evaluation of an AR-Assisted System for Standardizing Spirometry', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Evaluation of an Augmented Reality Assisted System for Standardizing Spirometry (AR-SPIRO Trial): Protocol for a Two-phase Validation and Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2026-KY-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AR-Assisted Guidance Group', 'description': 'Participants in this group will perform spirometry using an augmented reality (AR) assisted system. The system consists of a portable spirometer, a mobile terminal (iPad) for real-time data processing, and AR glasses. Participants will receive synchronized visual animations and voice interactive prompts via the AR glasses to complete the breathing maneuvers autonomously. A technician will assist with equipment wearing and safety monitoring but will not provide verbal or gestural coaching.', 'interventionNames': ['Device: AR-Assisted Spirometry Guidance System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Technician-led Guidance Group', 'description': 'Participants in this group will perform spirometry using the same portable spirometer model as the intervention group, but without the use of AR glasses. Guidance will be provided entirely by primary care technicians through standardized verbal coaching and physical gestures, strictly adhering to routine clinical practice and national spirometry standardization protocols. All technicians at the primary care sites will have undergone unified training before the study initiation.', 'interventionNames': ['Other: Routine Technician-led Spirometry Guidance']}], 'interventions': [{'name': 'AR-Assisted Spirometry Guidance System', 'type': 'DEVICE', 'otherNames': ['AR-SPIRO System'], 'description': 'An innovative digital health intervention integrating a portable spirometer (PF910), a mobile terminal (iPad) for real-time flow data processing via Bluetooth, and AR glasses (XREAL One). The system provides synchronized visual-auditory feedback and voice interactive prompts based on real-time expiratory flow data. Participants perform forced maneuvers following AR instructions autonomously while a technician monitors for safety without providing verbal or gestural coaching.', 'armGroupLabels': ['AR-Assisted Guidance Group']}, {'name': 'Routine Technician-led Spirometry Guidance', 'type': 'OTHER', 'description': 'Spirometry performed using the same PF910 spirometer model but without AR assistance. Guidance is provided entirely by a technician through standardized verbal and gestures coaching, strictly adhering to routine clinical practice and national spirometry standardization protocols. All technicians at primary care sites receive unified training on COPD guidelines and standardization protocols prior to study initiation.', 'armGroupLabels': ['Routine Technician-led Guidance Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tianqi Peng', 'role': 'CONTACT', 'email': '1600581183@qq.com', 'phone': '86+15020528636'}, {'name': 'Hongtao Niu', 'role': 'CONTACT', 'email': 'oxhongtao@163.com', 'phone': '86+15810619306'}], 'overallOfficials': [{'name': 'Hongtao Niu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Japan Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician, Department of Pulmonary and Critical Care Medicine', 'investigatorFullName': 'Hongtao Niu', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}