Evaluation of an AR-Assisted System for Standardizing Spirometry

Sponsor
China-Japan Friendship Hospital
Study ID
NCT07440420
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • AR-Assisted Spirometry Guidance System — DEVICE
    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 — OTHER
    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.

Study Details

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.

Key Dates

First listed
Feb 27, 2026
Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
710 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: AR-Assisted Guidance Group
    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.
  • Active Comparator: Routine Technician-led Guidance Group
    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.

Primary Outcome Measure

The consistency of quality grades distribution [ Time Frame: At the completion of the spirometry session (Day 1) ]

Central Contacts

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