Evaluation of an AR-Assisted System for Standardizing Spirometry

NCT07440420 | Not Yet Recruiting

• 1 other identifier: 2026-KY-013
• Study Type: interventional
• Target: 710
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Augmented Reality; Spirometry; Chronic Obstructive Pulmonary Disease; Primary Health Care; Digital Health; Study Protocol

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At the completion of the spirometry session (Day 1)

Secondary Outcomes (4)

• Examination time (phase 2)

  At the completion of the spirometry session (Day 1)

• Success rate (phase 2)

  Through trial completion, an average of 2 months

• Participant satisfaction (phase 2)

  Immediately post-test

• Incremental Cost-Effectiveness Ratio (phase 2)

  At enrollment

Study Arms (2)

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.

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.

Other: Routine Technician-led Spirometry Guidance

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.

Also known as: AR-SPIRO System

AR-Assisted Guidance Group

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.

Routine Technician-led Guidance Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Hongtao Niu

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianqi Peng

CONTACT

86+15020528636; 1600581183@qq.com

Hongtao Niu

CONTACT

86+15810619306; oxhongtao@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share