Evaluation of an AR-Assisted System for Standardizing Spirometry

February 26, 2026 updated by: Hongtao Niu, China-Japan Friendship Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

710

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • AR-SPIRO System
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the completion of the spirometry session (Day 1)
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.
At the completion of the spirometry session (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the completion of the spirometry session (Day 1)
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.
Through trial completion, an average of 2 months
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.
Immediately post-test
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.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Investigators

  • Principal Investigator: Hongtao Niu, China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-KY-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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