UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049369 |
|---|---|
| Receipt number | R000055974 |
| Scientific Title | Saliva volume change measurement test by wearing a mask while sleeping |
| Date of disclosure of the study information | 2022/10/31 |
| Last modified on | 2023/11/01 10:04:09 |
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Basic information
Public title
Saliva volume change measurement test by wearing a mask while sleeping
Acronym
Saliva volume change measurement test by wearing a mask while sleeping
Scientific Title
Saliva volume change measurement test by wearing a mask while sleeping
Scientific Title:Acronym
Saliva volume change measurement test by wearing a mask while sleeping
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of wearing a mask at bedtime on the amount of change in saliva volume.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva volume before going to bed and when waking up
Key secondary outcomes
1. Salivary pH before bed/wake up
2. Questionnaire for feeling sleepy when waking up
3. Subjective evaluation when waking up
4. Room temperature/humidity while sleeping
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 without a mask. -> Wear non-woven mask A and sleep. -> Wear non-woven mask B and sleep.
Interventions/Control_2
Sleep without a mask. -> Wear non-woven mask B and sleep. -> Wear non-woven mask A and sleep.
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 can use each sample for 5 consecutive days during the test period.
3.Subjects who frequently or rather often use a mask at bedtime in the last year.
4.Subjects who have experienced removing the mask during sleep less than 1 out of 5-6 times.
5.Subjects who are conscious or somewhat conscious of mouth breathing during sleep for the past month.
6.Subjects who have noticed or are somewhat aware of dry mouth upon waking for the past month.
7.Subjects who are conscious or somewhat conscious of dry throat when waking up for the last month.
8.Subjects who have fully understood and given their written consent to participate in the study after receiving an explanation about this study.
Key exclusion criteria
1. Subjects who wish to exercise excessively (swimming, soccer, marathons, etc.), consume caffeine, or drink alcohol during the test period.
2. Subjects whose bedtime and wake-up time are not within 1 hour.
3. Subjects who regularly use pharmaceuticals or therapeutic devices (excluding health foods and supplements).
4. Subjects who have had a cold, flu, or other illness within one month of obtaining consent.
5. Subjects who had symptoms of sore throat within 1 month of obtaining consent.
6. Subjects who cannot voluntarily put on and take off the product (persons with dementia, etc.).
7. Subjects who have used the test product and have experienced any abnormalities.
8. Subjects with skin abnormalities such as wounds, swelling, eczema, etc.
9. Subjects deemed unsuitable by the researcher.
Target sample size
25
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 | Yoshinori |
| Middle name | |
| Last name | Tsuda |
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
08030106129
Homepage URL
y.tsuda@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
Asmark Co., Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | 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
25
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 | 10 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 29 | 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 | 31 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055974
