Chronic Obstructive Pulmonary DiseaseNCT07440420
Evaluation of an AR-Assisted System for Standardizing Spirometry
A study testing AR-Assisted Spirometry Guidance System and Routine Technician-led Spirometry Guidance in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- AR-Assisted Spirometry Guidance System and Routine Technician-led Spirometry Guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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
- Being tested
- AR-Assisted Spirometry Guidance System, Routine Technician-led Spirometry Guidance
- Keywords
- Augmented Reality, Spirometry, Chronic Obstructive Pulmonary Disease, Primary Health Care, Digital Health, Study Protocol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-Assisted Spirometry Guidance SystemDevice
Also called AR-SPIRO 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 GuidanceOther
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 group | Role | What they receive |
|---|---|---|
| AR-Assisted Guidance Group | Experimental | 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. Receives: Device: AR-Assisted Spirometry Guidance System |
| Routine Technician-led Guidance Group | Active comparator | 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. Receives: Other: Routine Technician-led Spirometry Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The consistency of quality grades distribution
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.
Measured: At the completion of the spirometry session (Day 1)
Number of attempts for a successful spirometry examination
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.
Measured: At the completion of the spirometry session (Day 1)
Secondary outcomes (4)
Examination time (phase 2)
The total duration from the initial instruction to the conclusion of the final maneuver.
Measured: At the completion of the spirometry session (Day 1)
Success rate (phase 2)
The proportion of participants achieving a successful examination in the Intention-to-Treat (ITT) population.
Measured: Through trial completion, an average of 2 months
Participant satisfaction (phase 2)
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.
Measured: Immediately post-test
Incremental Cost-Effectiveness Ratio (phase 2)
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongtao Niu, China-Japan Friendship Hospital
- Investigators
- Hongtao Niu, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440420
- Sponsor's protocol ID
- 2026-KY-013
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07440420
- Acronym / sponsor ID
- 2026-KY-013
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Augmented Reality, Spirometry, Chronic Obstructive Pulmonary Disease, Primary Health Care, Digital Health, Study Protocol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR-Assisted Guidance Group | Experimental | Device: AR-Assisted Spirometry Guidance SystemParticipants 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. |
| Routine Technician-led Guidance Group | Active comparator | Other: Routine Technician-led Spirometry GuidanceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Phase 1
- Age ≥ 18 years.
- Able to provide written informed consent.
- Phase 2
- Age ≥ 40 years.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR-Assisted Spirometry Guidance SystemAlso: AR-SPIRO SystemAn 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. | Device | AR-Assisted Guidance Group |
| Routine Technician-led Spirometry GuidanceSpirometry 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. | Other | Routine Technician-led Guidance Group |
Primary outcome
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.
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.
4 secondary outcomes
Examination time (phase 2)
Time frame: At the completion of the spirometry session (Day 1)
Success rate (phase 2)
Time frame: Through trial completion, an average of 2 months
Participant satisfaction (phase 2)
Time frame: Immediately post-test
Incremental Cost-Effectiveness Ratio (phase 2)
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongtao Niu principal investigator
China-Japan Friendship Hospital
Questions about this trial
What is this clinical trial studying?
A study testing AR-Assisted Spirometry Guidance System and Routine Technician-led Spirometry Guidance in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianqi Peng (86+15020528636, 1600581183@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The consistency of quality grades distribution (time frame: At the completion of the spirometry session (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.