UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035513 |
|---|---|
| Receipt number | R000040462 |
| Scientific Title | The anti-fatigue effects of functional sleepwear. |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2019/04/26 13:54:22 |
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Basic information
Public title
The anti-fatigue effects of functional sleepwear.
Acronym
The anti-fatigue effects of functional sleepwear.
Scientific Title
The anti-fatigue effects of functional sleepwear.
Scientific Title:Acronym
The anti-fatigue effects of functional sleepwear.
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of a functional sleepwear on quality of sleep and fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in autonomic nerve function after the intervention for 2 weeks.
Key secondary outcomes
1. Sleep efficiency of the intervention for 2 weeks.
2. Changes in cognitive function and subjective fatigue after the intervention for 2 weeks.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Wear the test sleepwear for 2-4 weeks. / Wash out for 1-4 weeks. / Wear the placebo sleepwear for 2-4 weeks.
Interventions/Control_2
Wear the placebo sleepwear for 2-4 weeks. / Wash out for 1-4 weeks. / Wear the test sleepwear for 2-4 weeks.
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1. Healthy women who are aged from 20 to 39 years.
2. Persons who can give written informed consents.
Key exclusion criteria
1. Persons who have medical history such as neurological disorder, cardiovascular disease, mental disorder and other serious disease.
2. Persons who have medical history of nervous system disease such as unconsciousness, coma, convulsion, etc.
3. Persons who are in treatment.
4. Persons who have medical history of allergic dermatitis and contact dermatitis.
5. Persons who have vision disorder and auditory disorder.
6. Persons who are pregnant or breastfeed or have pregnancy plan during this study.
7. Persons who are shift worker.
8. Persons who have irregular sleep.
9. Persons who are now participating in other clinical trials, or participated in other clinical trials within a month before obtaining his/her informed consent in this trial.
10. Persons who are judged not suitable to participate in this trial by investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Mizuno |
Organization
RIKEN
Division name
Health Evaluation Team
Zip code
650-0047
Address
6-7-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
TEL
078-569-8868
keimizuno@riken.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Mizuno |
Organization
RIKEN
Division name
Health Evaluation Team
Zip code
650-0047
Address
6-7-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
TEL
078-569-8868
Homepage URL
keimizuno@riken.jp
Sponsor or person
Institute
RIKEN
Institute
Department
Personal name
Funding Source
Organization
Familiar, 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
RIKEN
Address
2-2-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, JAPAN
Tel
078-306-3036
kobe-ankan@cdb.riken.jp
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
国立研究開発法人理化学研究所（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 31 | 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
28
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
| 2018 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 11 | Day |
Last modified on
| 2019 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040462
