UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043332
Receipt number 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 2021/10/29 15:33:28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Kirin Holdings Company, Limited

Institute

Department

Personal name



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

Completed

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 10 Month 29 Day



Link to view the page

Value
https://center6.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