UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026148 |
|---|---|
| Receipt number | R000030053 |
| Scientific Title | The effect of the functional mattress on sleep |
| Date of disclosure of the study information | 2017/02/15 |
| Last modified on | 2020/02/18 09:48:54 |
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Basic information
Public title
The effect of the functional mattress on sleep
Acronym
The effect of the functional mattress on sleep
Scientific Title
The effect of the functional mattress on sleep
Scientific Title:Acronym
The effect of the functional mattress on sleep
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exam the effect of the mattress on sleep
Basic objectives2
Others
Basic objectives -Others
sleep experiment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG during sleep
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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 in the functional mattress
Interventions/Control_2
Sleep in the usual mattress
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
| 29 | years-old | > |
Gender
Male
Key inclusion criteria
No sleep problem
Key exclusion criteria
Smoker
Shift worker
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Satoh |
Organization
University of Tsukuba
Division name
International Institute for integrative sleep medicine
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
TEL
029-853-5643
mk-satoh@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Satoh |
Organization
University of Tsukuba
Division name
International Institute for integrative sleep medicine
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
TEL
029-853-5643
Homepage URL
mk-satoh@md.tsukuba.ac.jp
Sponsor or person
Institute
International Institute for integrative sleep medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Nishikawa Sangyo Co.,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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.17241/smr.2019.00423
Number of participants that the trial has enrolled
10
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
| 2016 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 15 | Day |
Last modified on
| 2020 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030053
