Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07440420

Evaluation of an AR-Assisted System for Standardizing Spirometry

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Phase 1

  • Age ≥ 18 years.
  • Able to provide written informed consent.

Phase 2

  • Age ≥ 40 years.
  • Cumulative smoking history of ≥10 pack-years or history of biomass fuel exposure for ≥10 years.
  • Able to provide written informed consent.

Exclusion criteria

(both two phase):

  • 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.

Treatment and study plan

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.

Other names: AR-SPIRO System

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.

Primary outcomes

  1. The consistency of quality grades distribution

    Time frame: At the completion of the spirometry session (Day 1)

    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.

  2. Number of attempts for a successful spirometry examination

    Time frame: At the completion of the spirometry session (Day 1)

    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.

Secondary outcomes

  1. Examination time (phase 2)

    Time frame: At the completion of the spirometry session (Day 1)

    The total duration from the initial instruction to the conclusion of the final maneuver.

  2. Success rate (phase 2)

    Time frame: Through trial completion, an average of 2 months

    The proportion of participants achieving a successful examination in the Intention-to-Treat (ITT) population.

  3. Participant satisfaction (phase 2)

    Time frame: Immediately post-test

    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.

  4. Incremental Cost-Effectiveness Ratio (phase 2)

    Time frame: At enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongtao Niu

CONTACT

[email protected]

86+15810619306

Tianqi Peng

CONTACT

[email protected]

86+15020528636

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.