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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046177
Receipt No. 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 2021/11/25

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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.

MRI contraindications (except for those who have magnetic metals in their body or are claustrophobic. Specifically, those who have had head surgery, aneurysm clips, electrical stimulators, etc., history of epileptic seizures, trauma to the eyes from metal, metal grinding occupation, metal or metal fragments, artificial eyes or intraocular lenses, cochlear implants, intraaural prosthesis, permanent make-up, artificial or artistic make-up, cardiac pacemaker, implantable defibrillator, implantable pump, artificial heart valve, clip, stent, catheter, pregnant, intrauterine contraceptive device, artificial joint, etc.) In addition to the above, the principal investigator may include other subjects.
(2) 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 Frontier 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
Email 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 Frontier 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
Email uneme.kumiko.6m@kyoto-u.ac.jp

Sponsor
Institute Kyoto University, Institute for Frontier Life and Medical Sciences
Institute
Department

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 Frontier Life and Medical Sciences
Address Inter-Organ Communication Research Team
Tel 075-751-4804
Email 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 17 Day
Date of IRB
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

Management information
Registered date
2021 Year 11 Month 25 Day
Last modified on
2021 Year 11 Month 25 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051032

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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