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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035513
Receipt No. 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

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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
Email 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
Email keimizuno@riken.jp

Sponsor
Institute RIKEN
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040462

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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