healthy adult
Conditions
Interventions
Sleep without a mask. ->
Wear non-woven mask A and sleep. ->
Wear non-woven mask B and sleep.
Sleep without a mask. ->
Wear non-woven mask B and sleep. ->
Wear non-woven mask A and sleep.
Sponsors
Kobayashi Pharmaceutical Co., Ltd. Household Products Division Wellness Care R&D Group
Asmark Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Saliva volume before going to bed and when waking up | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYoshinori Tsuda
Kobayashi Pharmaceutical Co., Ltd. Household Products Division Wellness Care R&D Group
Outcome results
None listed