An innovative mobile tele-spirometry system: development and validation study:Assessment of Consistency

UMIN ID: UMIN000056577

Registered date:08/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy adults meeting the inclusion criteria
• Date of first enrollment: 2022/06/01
• Target sample size: 34
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): This study aims to conduct a randomized crossover trial comparing face-to-face spirometry and tele-spirometry. The objective is to evaluate the equivalence and consistency of measurement values between tele-spirometry and face-to-face spirometry.

Outcome(s)

• Primary Outcome: The primary outcome is the evaluation of the consistency of measurement values (vital capacity, forced vital capacity, forced expiratory volume in 1 second, peak expiratory flow, and extrapolated volume) between face-to-face spirometry and tele-spirometry. Additionally, the validity and reproducibility of these measurements will be assessed.
• Secondary Outcome: 1.Conducting a questionnaire survey with participants to evaluate the testing time and the number of test attempts. 2.Measuring noise levels in the testing environment to verify whether tele-spirometry contributes to improvements in the environment of testing and consultation rooms.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Individuals receiving treatment for acute cardiac, vascular, or respiratory diseases. 2.Individuals being monitored for chronic respiratory diseases (e.g., COPD, asthma). 3.Individuals receiving treatment or being monitored for active infections. 4.Individuals with a history of forced expiration- or cough-induced syncope. 5.Individuals with hearing impairments. 6.Other individuals deemed ineligible by the researcher.

Related Information

• Primary Sponsor: Juntendo University
• Source(s) of Monetary Support: Juntendo University