Healthy adult
Conditions
Interventions
1.Observation period for 1 week. 2.Applying a steam eye mask at bedtime once a day for 4 weeks.
1.Observation period for 1 week. 2.Applying a sham eye mask at bedtime once a day for 4 weeks.
Sponsors
Kao Corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Female with sleep difficulty 2.Female aged 20-49 3.Person who agrees to use the wearable device Fitbit.
Exclusion criteria
Exclusion criteria: 1.Subjects having no experience using a steam eye mask 2.Subjects having psychiatric disorders other than sleep disorder 3.Subjects having sleep disorders other than insomnia disorders (hypersomnolence disorder, breathing- related sleep disorders, parasomnias. etc.) 4.Subjects having caused the body trouble by periocular warming in the past 5.Subjects having following diseases; cardiovascular disease, a neuropsychiatric disorder (alcohol/drug dependence or abuse) 6.shift worker. 7.Subjects having changed their medications such as sleeping pills during the study period 8.Subjects having disorders (pain, pruritus, fever, diarrhea, frequent urination, etc.) obstruct sleep quality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of subjective sleep score and the mood states. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Objective sleep index from Fitbit -Profile of Mood States (POMS) -Trait Anxiety Inventory (STAI) -Psychological Well-being | — |
Countries
Japan
Contacts
Public ContactHotaka Takakuwa
Kao Corporation Personal Health Care Research Lab.
Outcome results
None listed