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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025428
Receipt No. R000029270
Scientific Title Clinical study on the relationships among subjective and objective fatigue, lifestyle, and vital information: Study 1
Date of disclosure of the study information 2016/12/27
Last modified on 2016/12/27

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Basic information
Public title Clinical study on the relationships among subjective and objective fatigue, lifestyle, and vital information: Study 1
Acronym Relationships among subjective and objective fatigue, lifestyle, and vital information
Scientific Title Clinical study on the relationships among subjective and objective fatigue, lifestyle, and vital information: Study 1
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuyoshi Watanabe
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
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
1st name
Middle name
Last name Kei Mizuno
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2014 Year 09 Month 29 Day
Date of IRB
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

Other
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

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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