Effect of NP-2006 on Sleep Efficiency and Quality in Healthy Volunteers With Persistent Subclinical Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
研究概览
简要总结
The main objective will be to assess the effect of NP-2006 on sleep efficiency in volunteers presented with persistent subclinical insomnia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who agreed to participate in this study and signed a written consent form
- •Adults aged 19 to 65 years, male or female
- •Those with poor sleep quality (PSQI score > 5 points)
排除标准
- •Those with severe sleep disturbances (ISI ≥ 22 points)
- •Those with severe daytime sleepiness (ESS ≥ 16 points)
- •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
- •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
- •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)
- •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
结局指标
主要结局
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change from Baseline in Sleep Efficiency measured by Actigraphy(Baseline (Day 0), End of treatment (Day 29))
- Change from Baseline in Total Sleep Time (TST) from Sleep Diary(Baseline (Day 0), End of treatment (Day 29))
- Change from Baseline in Subjective Sleep Quality Score(Baseline (Day 0), End of treatment (Day 29))
- Change from Baseline in Sleep Latency measured by Polysomnography (PSG)(0, 4, 8, 12 weeks)