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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032328
Receipt No. R000036868
Scientific Title The anti-fatigue effects based on improvement of sleep by using mattress in children
Date of disclosure of the study information 2019/03/31
Last modified on 2018/04/20

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Basic information
Public title The anti-fatigue effects based on improvement of sleep by using mattress in children
Acronym The anti-fatigue effects of mattress in children
Scientific Title The anti-fatigue effects based on improvement of sleep by using mattress in children
Scientific Title:Acronym 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
1st name
Middle name
Last name Kei Mizuno
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
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
1st name
Middle name
Last name Kei Mizuno
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2015 Year 04 Month 07 Day
Date of IRB
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

Other
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

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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