UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049211 |
|---|---|
| Receipt number | R000055883 |
| Scientific Title | Sleep-quality assessment during mouth-tape use in capsule hotel sleep facilities |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2022/10/13 20:37:32 |
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Basic information
Public title
Sleep-quality assessment during mouth-tape use in capsule hotel sleep facilities
Acronym
Sleep-quality assessment during mouth-tape use in capsule hotel sleep facilities
Scientific Title
Sleep-quality assessment during mouth-tape use in capsule hotel sleep facilities
Scientific Title:Acronym
Sleep-quality assessment during mouth-tape use in capsule hotel sleep facilities
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of using mouth-tape on sleep quality
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep data
Key secondary outcomes
Questionnaire responses
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Sleep with mouth-tape -> Sleep without mouth-tape
Interventions/Control_2
Sleep without mouth-tape -> Sleep with mouth-tape
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Subjects who are 20 years of age or older and 60 years of age or younger at the time of obtaining consent
2.Subjects who are usually aware of mouth breathing or snoring symptoms.
3.Subjects who stay for two or more consecutive days during the exam.
4.Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and being able to sign a written informed consent
Key exclusion criteria
1.BMI less than or equal to 18.5 or greater than or equal to 25.0
2.Subjects who are drinking on the day of the exam and wish to drink during the exam.
3.Subjects who regularly use some kind of medicine or a therapeutic device
4.Subjects with nasal congestion or disorders of nasal breathing or subjects with symptoms of nausea or nausea.
5.Subjects who are unable to put on or take off the product by their own will (such as those with dementia)
6.Subjects who have used the test article and have experienced any abnormalities
7.Subjects who have weak (Easily irritated, prone to rashes, etc.) lips
8. Subjects deemed unsuitable by the researcher
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Kiyoe |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Household Products Division Wellness Care R&D Group
Zip code
567-0057
Address
1-30-3,Toyokawa, Ibaraki-city, Osaka, Japan
TEL
072-640-0125
r.kiyoe@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Shirato |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Household Products Division Wellness Care R&D Group
Zip code
567-0057
Address
1-30-3,Toyokawa, Ibaraki-city, Osaka, Japan
TEL
08041982183
Homepage URL
m.shirato@kobayashi.co.jp
Sponsor or person
Institute
Kobayashi Pharmaceutical Co., Ltd.
Household Products Division Wellness Care R&D Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
nine hours Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
株式会社 ナインアワーズ 赤坂sleep lab店
株式会社 ナインアワーズ 大手町店
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 13 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 13 | Day |
Last modified on
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055883
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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