Evaluation of an AR-Assisted System for Standardizing Spirometry
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years.
Able to provide written informed consent.
Age ≥ 40 years.
Cumulative smoking history of ≥10 pack-years or history of biomass fuel exposure for ≥10 years.
Disqualifiers
Presence of absolute or relative contraindications to spirometry.
Current pregnancy.
Severe vision or hearing impairments that preclude the effective use of Augmented Reality (AR) glasses.
Trial design
Design model
Parallel
Treatments tested in this trial
AR-Assisted Spirometry Guidance System
DeviceAn 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.
Routine Technician-led Spirometry Guidance
Other interventionSpirometry 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.
Treatment groups
710 Participants
are divided into 2 treatment groupsGroup A: AR-Assisted Guidance GroupExperimental treatment 1 intervention
Group B: Routine Technician-led Guidance GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The consistency of quality grades distribution
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.
Time frame
At the completion of the spirometry session (Day 1)2
Number of attempts for a successful spirometry examination
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.
Time frame
At the completion of the spirometry session (Day 1)Secondary outcomes
1
Examination time (phase 2)
The total duration from the initial instruction to the conclusion of the final maneuver.
Time frame
At the completion of the spirometry session (Day 1)2
Success rate (phase 2)
The proportion of participants achieving a successful examination in the Intention-to-Treat (ITT) population.
Time frame
Through trial completion, an average of 2 months3
Participant satisfaction (phase 2)
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.
Time frame
Immediately post-test4
Incremental Cost-Effectiveness Ratio (phase 2)
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.
Time frame
At enrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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