UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036027 |
|---|---|
| Receipt number | R000041034 |
| Scientific Title | A monitoring study on the real-time sensing of human response (a single-arm intervention study) |
| Date of disclosure of the study information | 2019/03/03 |
| Last modified on | 2024/05/21 13:13:10 |
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Basic information
Public title
A monitoring study on the real-time sensing of human response (a single-arm intervention study)
Acronym
A monitoring study on the real-time sensing of human response (a single-arm intervention study)
Scientific Title
A monitoring study on the real-time sensing of human response (a single-arm intervention study)
Scientific Title:Acronym
A monitoring study on the real-time sensing of human response (a single-arm intervention study)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate environmental influences on human.
Basic objectives2
Others
Basic objectives -Others
Research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nose temperature, heart rate, acceleration, amount of activity, brain activity, degree of fatigue, sleep quality
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Airflow amount through an air conditioner unit, illuminance in a room, stretching, and meditation
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Age 20 years and older
2. Males
3. Undergraduate students
4. Those who can sleep at least 6 hours per night on a daily basis as well as during the exam period.
5. Non-smokers
6. Those who can complete the testing schedule.
7. Those who can submit an informed consent document.
Key exclusion criteria
1. Those who are currently receiving treatment for some kind of systemic disease.
2. Those who seem to have difficulty making their own judgements (due to dementia, mental illness, etc.)
3. Those who were determined by the principal investigator to be unsuitable for participation in this study.
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Harimoto |
Organization
TAISEI Corporation
Division name
Valuable Space Research Section,Urban Engineering Research Department,Technology Center
Zip code
245-0051
Address
344-1,Nase-cho,Totsuka-ku,Yokohama,Japan
TEL
090-9026-7660
kazuyoshi.harimoto@sakura.taisei.co.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Harimoto |
Organization
TAISEI Corporation
Division name
Valuable Space Research Section,Urban Engineering Research Department,Technology Center
Zip code
245-0051
Address
344-1,Nase-cho,Totsuka-ku,Yokohama,Japan
TEL
090-9026-7660
Homepage URL
kazuyoshi.harimoto@sakura.taisei.co.jp
Sponsor or person
Institute
TAISEI Corporation
KANEKA Corporation
Institute
Department
Personal name
Funding Source
Organization
TAISEI Corporation
KANEKA Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.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
| 2019 | Year | 03 | Month | 03 | 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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2019 | 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
| 2019 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041034
