UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050299 |
|---|---|
| Receipt number | R000057273 |
| Scientific Title | Observational study on sleep-related indicators. |
| Date of disclosure of the study information | 2023/02/13 |
| Last modified on | 2023/12/25 15:12:38 |
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Basic information
Public title
Observational study on sleep-related indicators.
Acronym
Observational study on sleep-related indicators.
Scientific Title
Observational study on sleep-related indicators.
Scientific Title:Acronym
Observational study on sleep-related indicators.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the relevance of sleep-related indicators.
Basic objectives2
Others
Basic objectives -Others
Observational study on sleep-related indicators.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective indicators and subjective assessments of sleep.
Key secondary outcomes
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy male and female who are at least 20 years old at the time of consent and less than 65 years old at the end of the study.
(2)Subjects who can make self-judgment and voluntarily gave informed consent.
Key exclusion criteria
(1) Subjects who have been diagnosed with sleep disorders.
(2) Subjects taking medications (e.g., sleep aids) that are thought to have the potential to affect the study and whose use cannot be restricted during the study period.
(3) Subjects who will be in a time zone during the study period for business or travel.
(4) Subjects who have allergic to metal.
(5) Females in pregnancy, lactation and scheduled pregnancy period.
(6) Subjects being under other clinical tests, or partook in those within the past four weeks.
(7) Subjects who meet any of the following:
(a) suffering from heart, liver, or kidney disease (including complications of other diseases)
(b) having a history of cardiovascular disease
(c) diabetes
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Minami |
Organization
Suntory beverage & Food limited
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-3182-6161
Hisako_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Endo |
Organization
Suntory beverage & Food limited
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-3182-5680
Homepage URL
Megumi_Endo@suntory.co.jp
Sponsor or person
Institute
Suntory beverage & Food limited
Institute
Department
Personal name
Funding Source
Organization
Suntory beverage & Food limited
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mibyou Research Ethics Review Committee
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
Tel
03-6272-9163
renraku@npo-mibyou.com
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 13 | 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
| 2023 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2023 | Year | 02 | Month | 10 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057273
| 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 |
