UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039275 |
|---|---|
| Receipt number | R000044765 |
| Scientific Title | Research and development of multi-vital sign measurement technology based on respiratory information |
| Date of disclosure of the study information | 2020/11/27 |
| Last modified on | 2025/03/27 17:49:03 |
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Basic information
Public title
Research and development of multi-vital sign measurement technology based on respiratory information
Acronym
Research and development of multi-vital sign measurement technology based on respiratory information
Scientific Title
Research and development of multi-vital sign measurement technology based on respiratory information
Scientific Title:Acronym
Research and development of multi-vital sign measurement technology based on respiratory information
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Pneumology | Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of vital sign measuring device attached on mask.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
spirometry, electrocardiogram, blood pressure
Key secondary outcomes
questionnaire (age, height, body weight, normal temperature, medical history, history of smoking, impression of this examination)
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
| Device,equipment |
Interventions/Control_1
Applicants will wear vital sign measuring device attached on mask for measurement of the ventilation and ECG at resting condition.
The results will be compared with those of a routine spirometry test, ECG test, and blood pressure.
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
| 20 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adults with 20's
Applicants who are able to read and understand the informed consent form and will sign the informed consent.
Key exclusion criteria
Those who feel uncomfortable during the study.
Those who are judged inappropriate for the cooperation of this study by the investigator in charge.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Kawabe |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Radiological and Medical Laboratory Sciences
Zip code
461-8673
Address
1-1-20 Daiko-minami, Higashi-ku, Nagoya
TEL
052-719-1547
kawabe@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Miyoko |
| Middle name | |
| Last name | Matsushima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Radiological and Medical Laboratory Sciences
Zip code
461-8673
Address
1-1-20 Daiko-minami, Higashi-ku, Nagoya
TEL
052-719-1197
Homepage URL
matsu@met.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Nagoya University Graduate School of Medicine
Address
65 Tsuruma-cho, Showa-ku, Nagoya
Tel
052-744-2423
ethics@med.nagoya-u.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
| 2020 | Year | 11 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2026 | 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
| 2020 | Year | 01 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044765
