UMIN-CTR Clinical Trial

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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