Evaluation of an AR-Assisted System for Standardizing Spirometry

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство 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.
• Другое 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.

Первичные конечные точки

• The consistency of quality grades distribution [Срок оценки: At the completion of the spirometry session (Day 1)]
• Number of attempts for a successful spirometry examination [Срок оценки: At the completion of the spirometry session (Day 1)]

Вторичные конечные точки (4)

• Examination time (phase 2) [Срок оценки: At the completion of the spirometry session (Day 1)]
• Success rate (phase 2) [Срок оценки: Through trial completion, an average of 2 months]
• Participant satisfaction (phase 2) [Срок оценки: Immediately post-test]
• Incremental Cost-Effectiveness Ratio (phase 2) [Срок оценки: At enrollment]

Критерии участия

Критерии включения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07440420 · 2026-KY-013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗