Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:47 AM
Study NCT ID:
NCT07440420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an AR-Assisted System for Standardizing Spirometry
Sponsor:
China-Japan Friendship Hospital
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: