UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056669 |
|---|---|
| Receipt number | R000064760 |
| Scientific Title | An innovative mobile tele-spirometry system: development and validation study:Assessment of Superiority |
| Date of disclosure of the study information | 2025/01/10 |
| Last modified on | 2025/01/08 20:25:57 |
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Basic information
Public title
An innovative mobile tele-spirometry system: development and validation study:Assessment of Superiority
Acronym
An innovative mobile tele-spirometry system: development and validation study
Scientific Title
An innovative mobile tele-spirometry system: development and validation study:Assessment of Superiority
Scientific Title:Acronym
An innovative mobile tele-spirometry system: development and validation study
Region
| Japan |
Condition
Condition
Healthy adults meeting the inclusion criteria
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a mobile tele-spirometry system by integrating a communication system using widely available information and communication technology (ICT) devices, a laptop computer, and a portable, easy-to-maintain flow meter, and to evaluate its feasibility. Face-to-face spirometry will be performed by under-skilled examiners (those who conduct spirometry less than once every six months), while remote testing using mobile tele-spirometry will be conducted by highly skilled examiners (those proficient in spirometry). The superiority based on skill level will be compared.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
Conducting a questionnaire survey with participants to evaluate the testing time and the number of test attempts.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
This study will conduct a randomized crossover trial comparing face-to-face spirometry and telespirometry to evaluate the advantage of testing skills.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 years or older who have never undergone spirometry.
Key exclusion 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.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Ueki |
Organization
Juntendo University Graduate School of Health Care and Nursing
Division name
Clinical Research Unit of Respiratory Pathophysiology
Zip code
279-0023
Address
2-5-1, Takasu, Urayasu City, Chiba
TEL
0473553111
junueki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Matsuki |
Organization
Juntendo University Graduate School of Health Care and Nursing
Division name
Clinical Research Unit of Respiratory Pathophysiology
Zip code
279-0023
Address
2-5-1, Takasu, Urayasu City, Chiba
TEL
0473553111
Homepage URL
mmatsuki@bgu.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-1-1 Hongo Bunkyo-ku Tokyo
Tel
0338133111
junueki@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064760
