Sleep evaluation study after intake of the test food in health care workers
Not Applicable
- Conditions
- Healthy Volunteer
- Registration Number
- JPRN-UMIN000044323
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1)Persons who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study. 2)Persons who have allergy. 3)Others who are judged unsuitable as subjects by principal investigator or principal researcher (e.g., sleep apnea syndrome).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep-related indices (3DSS and sleep duration, awake time, sleep score, heart rate during sleep, autonomic function)
- Secondary Outcome Measures
Name Time Method (Secondary outcomes) Discomfort due to wearing masks, fatigue and stress at work, number of errors at work (Safety evaluation) General physical findings (subjective symptoms, objective findings), vital signs (weight, body temperature, blood pressure, pulse rate), frequency of adverse events