UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046177 |
|---|---|
| Receipt number | R000051032 |
| Scientific Title | Research on how the usage of online meeting systems, robots and avatars affects humans |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2024/11/27 09:01:31 |
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Basic information
Public title
Research on the effects of device use on humans
Acronym
Research on how the usage of devices affects humans
Scientific Title
Research on how the usage of online meeting systems, robots and avatars affects humans
Scientific Title:Acronym
Research on how the usage of devices affects humans
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the effects of device use on humans
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood metabolites and soluble factors, gene expression changes in immune cells, and changes in biological signals (pre- and post-device use)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Use of online meeting systems
Interventions/Control_2
Use of robots
Interventions/Control_3
Use of avatars
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who are between 20 and 89 years of age, have Japanese nationality (limited to Asian race), have a BMI between 18.5 and 30.0, and weigh 40 kg or more, and have been given a full explanation of the study before enrolling in the study and have obtained written consent from the subject after understanding the details of the study.
Key exclusion criteria
Those who have or are currently suffering from clinically problematic hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or psychological disorders; those who have a history of serious head and spinal cord trauma, surgery, gastrointestinal tract, urinary tract bleeding, major surgery, or serious non-head trauma within 3 months; and those who are pregnant or breastfeeding.
In addition to the above, the principal investigator may include other subjects. Others who are judged by the principal investigator to be ineligible for inclusion (e.g., those with extreme sleep disorders or excessive stress, those with symptoms such as menopausal disorders, those who use video conferencing systems excessively, etc.).In addition, students and staff members who belong to the laboratories of the principal investigators and subcontractors are not considered research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinpei |
| Middle name | |
| Last name | Kawaoka |
Organization
Kyoto University, Institute for Life and Medical Sciences
Division name
Inter-Organ Communication Research Team
Zip code
606-8507
Address
53 kawahara-cho, Shogoin, Kyoto, Japan
TEL
075-51-4804
kawaokashinpei@infront.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Uneme |
Organization
Kyoto University, Institute for Life and Medical Sciences
Division name
General Affairs
Zip code
606-8507
Address
53 kawahara-cho, Shogoin, Kyoto, Japan
TEL
075-751-4604
Homepage URL
uneme.kumiko.6m@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University, Institute for Life and Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology
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
Kyoto University, Institute for Life and Medical Sciences
Address
Inter-Organ Communication Research Team
Tel
075-751-4804
kawaokashinpei@infront.kyoto-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
| 2021 | Year | 12 | Month | 01 | 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
| 2021 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data are being collected and analyzed.
Management information
Registered date
| 2021 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051032
