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The main objective will be to assess the effect of NP-2006 on sleep efficiency in volunteers presented with persistent subclinical insomnia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A (NP-2006 first, then Placebo) | Experimental | Group that took tablets containing 500mg of NP-2006 (NP-2006, crystalline cellulose, tapioca starch, hydroxypropylmethylcellulose, etc.) 30 to 60 minutes before going to sleep |
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| Sequence B (Placebo first, then NP-2006) | Placebo Comparator | Group that took tablets not containing NP-2006 (crystalline cellulose, maltodextrin, lactose mixed powder, hydroxypropylmethylcellulose, etc.) 30 to 60 minutes before bedtime |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP-2006 | Dietary Supplement | Take a tablet containing 500 mg of NP-2006 once a day, 30 to 60 minutes before bedtime for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score | The PSQI is a self-report questionnaire that assesses sleep quality. The total score ranges from 0 to 21, where lower scores indicate better sleep quality. A decrease in the score represents an improvement in sleep health. | Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks |
| Change from Baseline in Insomnia Severity Index (ISI) Score | The ISI is a brief instrument that assesses the severity of insomnia. The total score ranges from 0 to 28, where 0-7 indicates 'no clinically significant insomnia' and higher scores indicate more severe insomnia. A lower score represents a better outcome (improvement in insomnia symptoms). | Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks |
| Change from Baseline in Epworth Sleepiness Scale (ESS) Score | The ESS is used to determine the level of daytime sleepiness. The total score ranges from 0 to 24. A lower score indicates less daytime sleepiness, representing a better outcome. | Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Sleep Efficiency measured by Actigraphy | Sleep efficiency is the ratio of total sleep time to time spent in bed, measured using a wrist-worn actigraph. The value is expressed as a percentage (%). A higher percentage indicates better sleep quality. | Baseline (Day 0), End of treatment (Day 29) |
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Inclusion Criteria:
Exclusion Criteria:
Those with severe sleep disturbances (ISI ≥ 22 points)
Those with severe daytime sleepiness (ESS ≥ 16 points)
Those with the following conditions:
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.
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
Those receiving hormone therapy
Those who regularly consume excessive alcohol
Those who smoke excessively (> 10 cigarettes/day) or show withdrawal symptoms
Those who consume excessive amounts of caffeine (> 3 cups/day)
Those who work night shifts or have irregular bedtimes due to their job
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
Those with a BMI of 18 kg/m2 or less or 35 kg/m2 or more
Those who have continuously taken herbal medicines or health functional foods that may affect sleep within 1 month of the first visit
Those who are hypersensitive to ingredients in the test or control foods or have experienced severe food allergies
Those who have participated in a clinical trial within 1 month of the first visit
Those who are pregnant or lactating, or who are planning to become pregnant
Those who the researcher deems unsuitable for participation in this study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement | Take a placebo tablet (identical in appearance to NP-2006 but containing no active ingredients) once a day, 30 to 60 minutes before bedtime for 4 weeks. |
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| Change from Baseline in Total Sleep Time (TST) from Sleep Diary |
Participants recorded their total sleep time daily in a sleep diary. The unit of measure is minutes (min). A higher value indicates an improvement in sleep duration and health. |
| Baseline (Day 0), End of treatment (Day 29) |
| Change from Baseline in Subjective Sleep Quality Score | Participants rated their sleep quality on a 5-point Likert scale, where 1 indicates 'Very Poor' and 5 indicates 'Very Good'. A higher score represents a better outcome (improved sleep quality). | Baseline (Day 0), End of treatment (Day 29) |
| Change from Baseline in Sleep Latency measured by Polysomnography (PSG) | Sleep latency is the time it takes to fall asleep from lights-out, measured by professional PSG equipment. The unit of measure is minutes (min). A lower value indicates a better outcome (faster sleep onset). | 0, 4, 8, 12 weeks |
| D001523 | Mental Disorders |