UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024034 |
|---|---|
| Receipt number | R000027641 |
| Scientific Title | Investigation to evaluate the efficacy of novel measurement method for fatigue. |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2017/10/02 18:06:54 |
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Basic information
Public title
Investigation to evaluate the efficacy of novel measurement method for fatigue.
Acronym
Investigation to evaluate the efficacy of novel measurement method for fatigue.
Scientific Title
Investigation to evaluate the efficacy of novel measurement method for fatigue.
Scientific Title:Acronym
Investigation to evaluate the efficacy of novel measurement method for fatigue.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of novel measurement method for fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between data from autonomic nerve function measured by novel device and standard device.
Key secondary outcomes
Subjective fatigue
Cognitive function
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
| 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, mental disorder, vision disorder and other serious disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Tanaka |
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
+81-6-6485-0288
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
+81-6-6485-0288
Homepage URL
chsi-b@ado.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Center for Health Science Innovation
Institute
Department
Personal name
Funding Source
Organization
Ricoh Co., Ltd.
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
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 | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 09 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 06 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 08 | Day |
Date analysis concluded
Other
Other related information
Study design:Prospective study
Subject recruitment method:Website of Osaka City University Center for Health Science Innovation from May 2 to 27 in 2016.
Management information
Registered date
| 2016 | Year | 09 | Month | 13 | Day |
Last modified on
| 2017 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027641
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
