Healthy subjects
Conditions
Interventions
Sponsors
Leverage Brain Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy males and females equal to or more than 20 years and less than 65 years of age 2)Subjects who use Japanese as his/her primary language 3)Subjects who are working 4)Subjects who are aware of mental fatigue on a daily basis 5)Subjects who can use electronic diary application 6)Subjects who have received their second dose of COVID-19 vaccination and have a certificate of vaccination at the time of registration
Exclusion criteria
Exclusion criteria: 1)Subjects who have, have a history, are suspected of having, and/or have a daily medication for the following items: sinusitis, allergic rhinitis (hay fever, etc.), psychiatric disorders (depression, anxiety disorders, etc.), sleep apnea syndrome, restless legs syndrome, insomnia, etc., sleep-related illness, chronic fatigue syndrome, arrhythmia, heart disease, menopausal disorders, history of serious illness (malignancy, diabetes, liver disease (hepatitis), renal disease, cardiac disease, etc.) 2)Subjects who have a difficulty to perform the tests due to a decline in olfactory function, sight, or hearing 3)Subjects with a cardiac pacemaker 4)Subjects who are receiving hormone therapy 5)Those who are judged to be unsuitable as subjects based on the results of the subject background investigation or preliminary examinations 6)Subjects who may have allergies or skin irritation caused by test fragrances or alcohol 7)Subjects who are, or are planning to be pregnant or breastfeeding during test periods 8)Subjects who have irregular lifestyles due to night work, etc. 9)Subjects who plan to travel abroad or go on overseas business trips 10)Subjects who consistently drink more than the appropriate amount of alcohol 11)Smoker, or has smoked within 12 months prior to preliminary examinations 12)Subjects who continuously consume medicines, health foods, food for specified health uses, food with nutrient function claims, or food with functional claims containing ingredients that may affect mood, fatigue, stress, sleep, or the autonomic nervous system at least once a week 13)Subjects who continuously use fragrances such as perfume, aroma diffuser, aroma spray, aroma bath, incense, etc. at least once a week 14)Subjects who have participated in other clinical trials within one month prior to the preliminary examinations or plan to participate during the study period 15)Subjects who are ineligible due to principal investigator's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Profile of Mood States 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Profile of Mood States 2 Sleep Quality Index Autonomic Nerve System Test Uchida-Kraepelin Test Olfactory Function Test | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactShigeru Imai
Leverage Brain Inc. Clinical Trial Department
Outcome results
None listed