UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036144 |
|---|---|
| Receipt number | R000041181 |
| Scientific Title | A verification test of the sleep improving effect of test equipment use |
| Date of disclosure of the study information | 2020/03/19 |
| Last modified on | 2020/03/23 16:17:42 |
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Basic information
Public title
A verification test of the sleep improving effect of test equipment use
Acronym
A verification test of the sleep improving effect of test equipment use
Scientific Title
A verification test of the sleep improving effect of test equipment use
Scientific Title:Acronym
A verification test of the sleep improving effect of test equipment use
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify sleep improving effect of test equipment especially when using stretch function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*The sleep score (evaluated by single-channel EEG)
*OSA questionnaire
*Japanese version of the Epworth Sleepiness Scale
Key secondary outcomes
*The sleep diary
*The incidence of side effects and/or adverse events.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Sleeping with the functions of test equipment on every day, for a week. Resting for one week. Sleeping without the functions of the test equipment on every day, for a week.
Interventions/Control_2
Sleeping without the functions of test equipment on every day, for a week. Resting for one week. Sleeping with the functions of the test equipment on every day, for a week.
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
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Male and female aged 30 to 64 when consent acquisition.
2) Subjects who have their body length 150cm to 185cm.
3) Subjects who answered that they don't satisfy their sleeping in questionnaire at preliminary test.
4) Subjects who are able to change their bedding to certain air-stretch mattress.
5) Subjects who are able to store their usual bedding during test period
6) Subjects who have received enough explanation about this study and were able to understand that, then giving written informed consent.
Key exclusion criteria
1) Subjects who have previous and/or current medical history of sleep impairment, or subjects who are being treated because of sleep impairment now.
2) Subjects who have been diagnosed as sleep apnea syndrome, or subjects who have noticed as apnea by themselves.
3) Subjects who have diagnosed as chronic low back pain, cervical spondylosis and/or osteoporosis in past, those disease are concerned about influence to using test device including stretch function. Or subjects who are being treated for the disease above.
4) Subjects who know that they easily to be influenced their sleep by environment change, such as using other bedding.
5) Subjects who don't be able to use sleep scope (single-channel EEG) during test period.
6) Subjects who have a planning of business trip or travel with lodging even once.
7) Subjects who don't be able to quit drink alcohol during test period.
8) Subjects who excessive alcohol intake.
9) Subjects who regularly use medicines, functional foods, foods for specified health use and/or supplements those concerned about influence for sleep.
10) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
11) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
12) Subjects who have severe menstrual pain or are diagnosed premenstrual syndrome (PMS).
13) Subjects who get a skin rash by attaching adhesive tape, because sensitive skin.
14) Subjects who use pacemaker.
15) Subjects who easily to get motion sickness.
16) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
17) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Fujiwara |
Organization
CPCC Company Limited
Division name
Division of Clinical Research
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
0352973112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
0352973112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
MTG 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel
0352975548
IRB@cpcc.co.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 19 | 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
20
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 | 09 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 01 | 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
| 2019 | Year | 03 | Month | 10 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041181
