UMIN-CTR Clinical Trial

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
Last 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
1st 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