None listed
Conditions
Interventions
During 7 days of first term, suction the aroma component of black tea for 3 hours a day at bedtime under natural respiration. A day rest. During 7 days of second term, suction control for 3 hours a da
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Females aged 30 to 45 years old who can't sleep well physiologically. ( For examples, female who can't fall in sleep within 30 min, female who have middle awakening and/or female who are short of sleeping time) (2) Females who work over 4 days, 3.5 hours a day. (3) Females who can quit using of smartphone, cell phone and/or PC from one hour before bedtime. (4) Females who don't dislike black tea. (5) Females who can quit drinking alcohol and caffeine after 5 pm during the test. (6) Females who have no plan of going to travel and/or staying at outside of the home during the test. (7) Females who can smell the aroma of black tea by diffuser at their own home during the test. (8) Females who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.
Exclusion criteria
Exclusion criteria: (1) Females who have smoking habit. (2) Females who are cold-sensitive constitution. (including females like that who feel cold on their hands and foots even in summer) (3) Females with stuffy nose or subjects who can't identify the fragrance. (4) Females who are currently receiving medication due to treatment of disease. (5) Females who go to hospital and/or subject who receive medicine, for treatment of sleep disorder. (6) Females who use supplements and/or health foods suspected to have influence to sleep. (7) Females with high blood pressure symptoms such as systolic blood pressure of 160 mmHg and more or diastolic blood pressure of 100 mmHg and more. (8) Females who notice their menopausal symptom. (9) Females who are pregnant (including the possibility of pregnancy) or are lactating. (10) Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood. (11) In the past month, subjects who have had custom of taking or applying medicine for the treatment of diseases. (12) Subjects who themselves and/or their family are working for a company that develops, manufactures or sells health / functional foods and cosmetics. (13) Subjects who have environment for sleep with their children or family at bed time. (14)Others who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. OSA sleep inventory 2. Pittsburgh Sleep Quality Index | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SCL30 2. Activity level 3. The incidence of side effects and/or adverse events. | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Planning & Sales Department
Outcome results
None listed