UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059643 |
|---|---|
| Receipt number | R000068219 |
| Scientific Title | A study on the effect of nano-sized electrostatic atomized water particles on brain activation |
| Date of disclosure of the study information | 2025/11/15 |
| Last modified on | 2025/11/05 12:12:38 |
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Basic information
Public title
A study on the effect of nano-sized electrostatic atomized water particles on brain activation
Acronym
A study on the effect of nano-sized electrostatic atomized water particles on brain activation
Scientific Title
A study on the effect of nano-sized electrostatic atomized water particles on brain activation
Scientific Title:Acronym
A study on the effect of nano-sized electrostatic atomized water particles on brain activation
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of nano-sized electrostatic atomized water particles on brain activation and cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Neurophysiological measures during cognitive tasks (total-Hb of dorsolateral prefrontal cortex and medial prefrontal cortex, heart rate variability indices)
Key secondary outcomes
Accuracy and reaction time variability of Stroop Task, Trail Making Test, N-back Task and Go-NoGo Task
Videos during cognitive tasks
Participant's background information
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants take cognitive tasks in a room with nano-sized electrostatic atomized water particles. After a 30 minutes washout period, participants take cognitive tasks in a room without nano-sized electrostatic atomized water particles.
Interventions/Control_2
Participants take cognitive tasks in a room without nano-sized electrostatic atomized water particles. After a 30 minutes washout period, participants take cognitive tasks in a room with nano-sized electrostatic atomized water particles.
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
| 18 | years-old | <= |
Age-upper limit
| 34 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Living in Tokyo,Kanagawa,Chiba or Saitama.
Male and female adults(18-34 years old)
Right-handed
No health problem for now (No history of serious illness / mental disorder)
Having normal or corrected-to-normal vision for both eyes (greater than or equal to 0.7)
Key exclusion criteria
Smoker
Taking any medication on a daily basis
Pregnant
When the investigator in charge judges that participating in this experiment is not appropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Okada |
Organization
NeU Corporation
Division name
Neuromarketing Business Unit
Zip code
1010048
Address
2-2 Niikura Building, Kandatsukasamachi, Chiyoda-ku, Tokyo
TEL
0362509050
takuya.okada@neu-brains.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Okada |
Organization
NeU Corporation
Division name
Neuromarketing Business Unit
Zip code
1010048
Address
2-2 Niikura Building, Kandatsukasamachi, Chiyoda-ku, Tokyo
TEL
0362509050
Homepage URL
takuya.okada@neu-brains.com
Sponsor or person
Institute
NeU Corporation
Institute
Department
Personal name
Funding Source
Organization
Panasonic Corporation
Living Appliances and Solutions Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2025 | Year | 11 | Month | 15 | 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
| 2025 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 11 | 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
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068219
