Tokyo, April 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061325) titled 'The Relationship Between Well-Being and Psychophysiological Functions While Performing Task' on April 20.
Study Type:
Observational
Primary Sponsor:
Institute - National Institute of Advanced Industrial Science and Technology
Condition:
Condition - Healthy Adults.
This research aims to clarify the characteristics of physical and mental functions in individuals with a high level of "well-being," a concept of psychological health. Therefore, its application to individuals with illnesses is not currently planned.
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to clarify the relationship between well-being and the regulation of psychological and physical functions involved in task performance.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male
Key inclusion criteria - 1: Individuals who are able to provide written informed consent to participate in the study of their own free will.
2: Individuals who are able to travel to the experimental site without using public transportation, in order to avoid contact with an unspecified number of people and reduce the risk of infectious disease exposure.
3: Individuals who are aged between 20 and 40 years at the time of obtaining informed consent.
4: Individuals whose biological sex is male, in order to minimize the potential influence of hormonal fluctuations associated with the menstrual cycle.
5: Individuals who self-report having regular sleep-wake schedules (i.e., an established rhythm of waking in the morning and sleeping at night).
6: Individuals who self-report having regular meal times.
7: Individuals with normal visual function, defined as a visual acuity of 0.7 or higher (with correction by glasses or contact lenses if necessary), in order to appropriately perceive the visual stimuli presented in the experiment.
8: Individuals with normal hearing ability that does not interfere with daily conversation, in order to appropriately perceive the auditory stimuli presented in the experiment.
9: Individuals who have no difficulty with or resistance to the attachment of electrodes for physiological signal measurements on the head, face, neck, flanks, chest, abdomen, ears, and other body sites.
10: Individuals who are able to participate while wearing clothing consisting of separate upper and lower garments, to allow the attachment of multiple electrodes to the body.
11: Individuals who have no resistance to saliva collection.
12: Individuals who are able to refrain from tooth brushing, eating or drinking, smoking, and vigorous physical activity for at least one hour prior to saliva collection.
13: Individuals who do not participate in any other experiments during the period of participation in this study.
Key exclusion criteria - 1: Individuals who are currently taking medications that may affect the activity of the central nervous system, peripheral nervous system, endocrine system, or immune system.
2: Individuals who have current diseases or a medical history of diseases affecting organs that are considered to influence the activity of the central nervous system, peripheral nervous system, endocrine system, or immune system, including the brain, heart, blood vessels, thymus, lymph nodes, bone marrow, spleen, liver, and adrenal glands.
3: Individuals with a body mass index (BMI) of 25.0 or higher.
4: Individuals with a body mass index (BMI) of 18.5 or lower.
Target Size - 70
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 11 Month 26 Day
Date of IRB - 2025 Year 11 Month 26 Day
Anticipated trial start date - 2025 Year 11 Month 27 Day
Last follow-up date - 2027 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070166
Disclaimer: Curated by HT Syndication.