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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043332
Receipt No. R000049472
Scientific Title Effects of watching videos on brain function: a single-blind, crossover comparative study
Date of disclosure of the study information 2021/02/15
Last modified on 2021/02/15

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Basic information
Public title Effects of watching videos on brain function: a single-blind, crossover comparative study
Acronym Effects of watching videos on brain function: a single-blind, crossover comparative study
Scientific Title Effects of watching videos on brain function: a single-blind, crossover comparative study
Scientific Title:Acronym Effects of watching videos on brain function: a single-blind, crossover comparative study
Region
Japan

Condition
Condition Female and male adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigating the effects of watching videos on brain function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitive function test score
(Serial 7 subtraction, Digit Vigilance, Alphabetic Working Memory, N-back)
Key secondary outcomes Cerebral blood flow measurement
Autonomic nervous function
Mood state
Salivary stress markers
Subjective survey on videos

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Watching videos1
Interventions/Control_2 Watching videos2
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
40 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Males and females whose age is between 40 and 65 years old
2. Subjects who use Japanese as his/her primary language
Key exclusion criteria Subjects who
1.have hearing or visual impairment that interferes with daily life
2.are wearing a device that interferes with heart rate measurement (e.g., pacemaker)
3.developed symptoms of arrhythmia within 12 months
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Kuniaki
Middle name
Last name Obara
Organization Kirin Holdings Company, Limited
Division name Kirin Central Research Institute, Research & Development Division
Zip code 251-8555
Address Shonan-health-innovation-park 26-1 Muraoka-Higashi 2-chome Fujisawa Kanagawa Japan
TEL 080-1930-9932
Email k-obara@kirin.co.jp

Public contact
Name of contact person
1st name Tomoko
Middle name
Last name Kitani
Organization Hamamatsu City Hall
Division name Health Promotion Division
Zip code 432-8023
Address 2-11-2, Kamoe, Naka-ku, Hamamatsu, Japan.
TEL 053-453-6125
Homepage URL
Email kenko@city.Hamamatsu.shizuoka.jp

Sponsor
Institute Kirin Holdings Company, Limited
Institute
Department

Funding Source
Organization Kirin Holdings Company, Limited
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 Research Ethical Review Committee of Kirin Holdings Company, Ltd.
Address Nakano Central Park South, 4-10-2, Nakano, Nakano-ku, Tokyo, Japan
Tel 03-6837-4128
Email 02976_Ni@kirin.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
2021 Year 02 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
2021 Year 01 Month 18 Day
Date of IRB
2021 Year 01 Month 18 Day
Anticipated trial start date
2021 Year 02 Month 15 Day
Last follow-up date
2021 Year 10 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 02 Month 15 Day
Last modified on
2021 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049472

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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