UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025428 |
|---|---|
| Receipt number | 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 12:00:14 |
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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
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
chsi-b@ado.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029270
