Sleep Disorder (Disorder)
Conditions
Brief summary
The main objective will be to assess the effect of NP-2006 on sleep efficiency in volunteers presented with persistent subclinical insomnia
Interventions
DIETARY_SUPPLEMENTNP-2006
Take a tablet containing 500 mg of NP-2006 once a day, 30 to 60 minutes before bedtime for 4 weeks.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Hanpoong Nature Pharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score | Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks | 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. |
| Change from Baseline in Insomnia Severity Index (ISI) Score | Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks | 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). |
| Change from Baseline in Epworth Sleepiness Scale (ESS) Score | Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Sleep Efficiency measured by Actigraphy | Baseline (Day 0), End of treatment (Day 29) | 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. |
| Change from Baseline in Total Sleep Time (TST) from Sleep Diary | Baseline (Day 0), End of treatment (Day 29) | 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. |
| Change from Baseline in Subjective Sleep Quality Score | Baseline (Day 0), End of treatment (Day 29) | 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). |
| Change from Baseline in Sleep Latency measured by Polysomnography (PSG) | 0, 4, 8, 12 weeks | 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). |
Countries
South Korea
Outcome results
None listed