UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059554 |
|---|---|
| Receipt number | R000068120 |
| Scientific Title | Understanding the effectiveness of mouth tape and its association with respiratory events in a capsule hotel type sleeping facility |
| Date of disclosure of the study information | 2025/10/30 |
| Last modified on | 2025/10/27 17:43:46 |
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Basic information
Public title
Understanding the effectiveness of mouth tape and its association with respiratory events in a capsule hotel type sleeping facility
Acronym
Understanding the effectiveness of mouth tape and its association with respiratory events in a capsule hotel type sleeping facility
Scientific Title
Understanding the effectiveness of mouth tape and its association with respiratory events in a capsule hotel type sleeping facility
Scientific Title:Acronym
Understanding the effectiveness of mouth tape and its association with respiratory events in a capsule hotel type sleeping facility
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of using mouth tape during sleep and its association with respiratory events
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep measurement data
Key secondary outcomes
Observation of participant state/behavior using an infrared camera
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Sleeping with mouth tape
Interventions/Control_2
Sleeping with mouth tape- > Sleeping without mouth tape
Interventions/Control_3
Sleeping without mouth tape -> Sleeping with mouth tape
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
･Subjects who are over 20 years old and under 60 years old at the time of obtaining consent
･Subjects staying overnight for 1 or 2days during the study period
･Subjects who fully understood and provided written consent after receiving an explanation about this study before participating in the study
･Subjects who agree to keep the difference in their bedtime and wake-up time between the first and second nights within one hour, as much as possible (applicable to two-night participants)
Key exclusion criteria
･Subjects whose BMI is below 18.5 or above 30.0
･Subjects who wish to carry out the following items on the day of the test and during the test period-> Drinking alcohol, Excessive exercise, Caffeine intake after 6pm
･Subjects who regularly use some kind of medicine or treatment device･Subjects who are unable to put on and take offthis product voluntarily (such as those with dementia)
･Subjects who have used the test product and felt any abnormality
･Subjects whose sleep duration is extremely short (less than 6 hours) (for single-night participants).
･Subjects with a history of illness or treatment related to symptoms of nasal congestion or respiratory symptoms (within the past year)
･Subjects judged to be inappropriate by the person in charge of the research
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Kiyoe |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
R&D Headquarters Personal and Home Care Development Department Wellness Care Development Group
Zip code
567-0057
Address
1-30-3,Toyokawa, Ibaraki-city, Osaka, Japan
TEL
080-3452-9751
r.kiyoe@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Inoue |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
R&D Headquarters Personal and Home Care Development Department Wellness Care Development Group
Zip code
567-0057
Address
1-30-3,Toyokawa, Ibaraki-city, Osaka, Japan
TEL
080-4108-7549
Homepage URL
ke.inoue@kobayashi.co.jp
Sponsor or person
Institute
Kobayashi Pharmaceutical Co., Ltd. R&D Headquarters Personal and Home Care Development Department Wellness Care Development 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 赤坂店
株式会社ナインアワーズ 水道橋
店株式会社ナインアワーズ 浜松町店
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068120
