UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Anti-fatigue effects of healing.
Title of the study (Brief title)	Anti-fatigue effects of healing.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the anti-fatigue effect of images for acute mental fatigue.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of EEG and autonomic nerve function between viewing the test images and control images.
Key secondary outcomes	Subjective fatigue Cognitive function

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	To perform fatigue-inducing tasks while viewing test images regularly.
Interventions/Control_2	To perform fatigue-inducing tasks while viewing control images regularly.
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy persons who are aged from 20 to 49 years.
Key exclusion criteria	Persons who have medical history such as neurological disorder, vision disorder and other serious disease.
Target sample size	40

Research contact person
Name of lead principal investigator	Yasuyoshi Watanabe
Organization	Osaka City University
Division name	Center for Health Science Innovation
Address	9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL	+81-6-6485-0288
Email	chsi-b@ado.osaka-cu.ac.jp

Public contact
Name of contact person	Kei Mizuno
Organization	Osaka City University
Division name	Center for Health Science Innovation
Address	9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL	+81-6-6485-0288
Homepage URL
Email	chsi-b@ado.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Center for Health Science Innovation
Institute
Department

Funding Source
Organization	NTT DATA INSTITUTE OF MANAGEMENT CONSULTING, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	大阪市立大学健康科学イノベーションセンター（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 28 Day
Anticipated trial start date	2014 Year 02 Month 04 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry	2014 Year 03 Month 04 Day
Date trial data considered complete	2014 Year 04 Month 01 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 17 Day
Last modified on	2016 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027245