Observational studies to elucidate fatigue factors and mechanisms

UMIN ID: UMIN000055915

Registered date:09/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2024/11/09
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Analysis of the relationship between fatigue status and physical/mental measurement items
• Secondary Outcome: Analysis of the relationship between fatigue and autonomic nervous system activity, blood factors, and sebaceous RNA expression factors

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 59years-old
• Gender: Male and Female
• Exclude criteria: 1. Participants who suffer from chronic diseases other than allergic conditions such as allergic rhinitis (e.g., diabetes, hypertension, dyslipidemia, gout, renal diseases, rheumatoid arthritis, respiratory diseases) and are currently taking medication. 2. Participants deemed unable to participate in the trial by a physician due to liver, kidney, heart diseases, respiratory disorders, endocrine disorders, metabolic disorders, consciousness disorders, diabetes, or other diseases. 3. Participants diagnosed with chronic fatigue syndrome by a physician. 4. Participants currently suffering from mental disorders. 5. Participants suffering from sleep disorders such as insomnia or sleep apnea syndrome. 6. Participants who consume alcohol excessively [equivalent to 60g of alcohol/day or more]. 7. Participants who have donated 200mL or more of blood within one month or 400mL or more within three months prior to the start of this trial. 8. Participants using implanted medical devices such as pacemakers or implantable cardioverter defibrillators. 9. Participants suffering from skin diseases on the face (e.g., atopic dermatitis, acne vulgaris, psoriasis). 10. Participants using topical medications on the face. 11. Participants who work night shifts or rotational shifts and are not on a day shift schedule. 12. Participants currently participating in other clinical trials or planning to participate in other trials during the period of this trial. 13. Participants who are currently pregnant or intend to become pregnant during the trial period. 14. Participants deemed inappropriate for participation in this trial by the principal investigator.

Related Information

• Primary Sponsor: Kao Corporation
• Source(s) of Monetary Support: Kao Corporation