UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The anti-fatigue effects based on improvement of sleep by using mattress in children
Title of the study (Brief title)	The anti-fatigue effects of mattress in children
Region	Japan

Condition
Condition	Healthy child
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the anti-fatigue effects based on sleep-improvement of mattress for children's daily life.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in sleep state, subjective fatigue, autonomic nerve function and cognitive function after 4-weeks intervention.
Key secondary outcomes	Amount of daily activity

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) 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	Sleep of test mattress for 4 weeks. / Wash out for 4 weeks. / Sleep of placebo mattress for 4 weeks.
Interventions/Control_2	Sleep of placebo mattress for 4 weeks. / Wash out for 4 weeks. / Sleep of test mattress for 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	9 years-old <=
Age-upper limit	12 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Healthy children from the 4th grade to 6th grade. 2.Children who can understand about this study and agree to participate in this study.
Key exclusion criteria	1.Children who take treatment. 2.Children who usually take medicines or supplements. 3.Children with medical history of cardiovascular disease or nervous system disease. 4.Children with allergy. 5.Children with insomnia. 6.Children who sleep with their family or pets on the same mattress. 7.Children who are judged not suitable to participate in this trial by investigators.
Target sample size	35

Research contact person
Name of lead principal investigator	Kei Mizuno
Organization	Osaka City University
Division name	Center for Health Science Innovation
Address	9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL	+81-6-6485-0288
Email	chsi-b@ado.osaka-cu.ac.jp

Public contact
Name of contact person	Kei Mizuno
Organization	Osaka City University
Division name	Center for Health Science Innovation
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
Email	chsi-b@ado.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Center for Health Science Innovation
Institute
Department

Funding Source
Organization	Nishikawa Living inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2019 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 07 Day
Anticipated trial start date	2015 Year 06 Month 27 Day
Last follow-up date	2015 Year 09 Month 19 Day
Date of closure to data entry	2015 Year 11 Month 04 Day
Date trial data considered complete	2016 Year 03 Month 14 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 20 Day
Last modified on	2018 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036868