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Evaluation of an AR-Assisted System for Standardizing Spirometry
Sponsor: China-Japan Friendship Hospital
Summary
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.
Official title: Evaluation of an Augmented Reality Assisted System for Standardizing Spirometry (AR-SPIRO Trial): Protocol for a Two-phase Validation and Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
710
Start Date
2026-03
Completion Date
2026-06
Last Updated
2026-02-27
Healthy Volunteers
Yes
Conditions
Interventions
AR-Assisted Spirometry Guidance System
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.
Routine Technician-led Spirometry Guidance
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.