UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050380 |
|---|---|
| Receipt number | R000057367 |
| Scientific Title | Multi-omics analyses on how the use of video conference systems, robots, and avatars affect human physiology |
| Date of disclosure of the study information | 2023/02/20 |
| Last modified on | 2025/02/19 09:02:24 |
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Basic information
Public title
Studies on how the use of devices affects human physiology
Acronym
How the use of devices affect human physiology?
Scientific Title
Multi-omics analyses on how the use of video conference systems, robots, and avatars affect human physiology
Scientific Title:Acronym
Multi-omics analyses on how the use of devices affects human physiology
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to understand how the use of video conference systems, robots, and avatars affects human multi-omics network.
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
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Communications in person and virtual
Interventions/Control_2
Virtual communications with or without avatars
Interventions/Control_3
The use of communication robots
Interventions/Control_4
The use of gaming softwares
Interventions/Control_5
Multi-task intervention
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who are between 20 and 65 years of age, have Asian nationality, 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
Patients with the following clinically problematic diseases:
Hematological diseases
renal diseases
endocrine disease
Pulmonary disease
Gastrointestinal disease
Cardiovascular Diseases
Liver disease
Those with a history of, or currently suffering from, psychiatric or mental disorders
Those with a history of serious head and spinal cord trauma, surgery, gastrointestinal tract, urinary tract bleeding, major surgery, or serious non-head trauma within the past 3 months
Pregnant or lactating mothers.
The Principal Investigator will confirm whether or not the above conditions apply to the applicant at the time of application by e-mail, etc., and at the time of explanation. If the applicant is not sure, the Principal Investigator will contact a licensed physician on the spot to determine whether or not the condition applies to the applicant and whether or not the applicant may participate.
Other applicants who are deemed ineligible for inclusion by the Principal Investigator (e.g., those with extreme sleep disorders or excessive stress, those with symptoms such as menopausal disorders, etc.).
Students and staff members affiliated with the principal investigator's or subinvestigator's laboratory, as well as students who are involved in grade approval by the principal investigator or subinvestigator, will not be eligible for inclusion in the study.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Shinpei |
| Middle name | |
| Last name | KAWAOKA |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
980-8575
Address
4-1 Seiryocho, Aobaku, Sendai
TEL
022-717-8568
shinpei.kawaoka.c1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | Yoda |
Organization
Tohoku university
Division name
Institute of Development, Aging and Cancer
Zip code
980-8575
Address
4-1 Seiryocho, Aobaku, Sendai
TEL
022-717-8568
Homepage URL
mayuko.yoda.e8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
JST
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 Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 02 | Month | 20 | 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
| 2023 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 02 | 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
Open public recruiting
Management information
Registered date
| 2023 | Year | 02 | Month | 18 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057367
