NCT07440420

Evaluation of an AR-Assisted System for Standardizing Spirometry

Evaluation of an Augmented Reality Assisted System for Standardizing Spirometry (AR-SPIRO Trial): Protocol for a Two-phase Validation and Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 710 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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).

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-02-27
• Last updated: 2026-02-27