UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study on the relationships among subjective and objective fatigue, lifestyle, and vital information: Study 1
Title of the study (Brief title)	Relationships among subjective and objective fatigue, lifestyle, and vital information
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of subjective and objective fatigue by measurements of autonomic nerve function during daytime and night.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Autonomic nerve function during daytime and night(heart rate measurementand sleep measurement)
Key secondary outcomes	None

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy male and females between 20 and 60 years old
Key exclusion criteria	1)Pregnant 2)Individuals taking chronic treatment or medications 3)Individuals with a history of cardiovascular disease 4)Individuals with medical history of nervous system disease such as unconsciousness, coma, and convulsion, etc. 5) Individuals with sleep disorder 6)Individuals with skin allergy 7) Individuals taking much alcohol (more than 30g/day in average) 8) Individuals considered as inappropriate to participate in this study by principal investigators
Target sample size	60

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	06-6485-0288
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	06-6485-0288
Homepage URL
Email	chsi-b@ado.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	Omron Healthcare Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Omron Healthcare Co., Ltd.
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 12 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 29 Day
Anticipated trial start date	2014 Year 11 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Cohort study Recruitment of participants (Duration, July 2015; Participants who satisfied the inclusion criteria) Measurements (ECG/Sleep monitoring, VAS, and oxidative stress marker, etc.)

Management information
Registered date	2016 Year 12 Month 27 Day
Last modified on	2016 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029270