UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032328 |
|---|---|
| Receipt number | 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 14:32:49 |
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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
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
chsi-b@ado.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Center for Health Science Innovation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036868
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
