Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07485959
Eligibility Criteria:
Inclusion Criteria:
1. Those who agreed to participate in this study and signed a written consent form
2. Adults aged 19 to 65 years, male or female
3. Those with poor sleep quality (PSQI score \> 5 points)
Exclusion Criteria:
1. Those with severe sleep disturbances (ISI ≥ 22 points)
2. Those with severe daytime sleepiness (ESS ≥ 16 points)
3. Those with the following conditions:
* Snoring, sleep apnea, restless legs syndrome, periodic limb movement disorder (PLMD), depression, narcolepsy, or respiratory disease that cause sleep disturbances
* Itching, nocturia, chronic pain, or muscle cramps that affect sleep
* Uncontrolled diabetes or hypertension
4. Those experiencing changes that could cause excessive stress within 2 weeks of the first visit: death of a spouse, family discord, lawsuits/disputes, sudden financial difficulties, immigration, etc.
5. Those taking medications (corticosteroids, psychotropic medications, etc.) that could affect sleep within 1 month of the first visit or expected to take them during the study participation
6. Those receiving hormone therapy
7. Those who regularly consume excessive alcohol
* Men \> 210 g/week (approximately 4 bottles of soju/week, approximately 4 glasses/day)
* Women \> 140 g/week (approximately 2.5 bottles of soju/week, approximately 2.5 glasses/day)
8. Those who smoke excessively (\> 10 cigarettes/day) or show withdrawal symptoms
9. Those who consume excessive amounts of caffeine (\> 3 cups/day)
10. Those who work night shifts or have irregular bedtimes due to their job
11. Those who have traveled or plan to travel long distances to a country with a different time zone within 1 month of the first visit
12. Those with a BMI of 18 kg/m2 or less or 35 kg/m2 or more
13. Those who have continuously taken herbal medicines or health functional foods that may affect sleep within 1 month of the first visit
14. Those who are hypersensitive to ingredients in the test or control foods or have experienced severe food allergies
15. Those who have participated in a clinical trial within 1 month of the first visit
16. Those who are pregnant or lactating, or who are planning to become pregnant
17. Those who the researcher deems unsuitable for participation in this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT07485959
Study Brief:
Protocol Section:
NCT07485959