KCT0009096招募中未知
An 8-week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of probiotics NVP-1704 on sleep improvement
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) You are at least 19 years old and under 65 years old
- •2) Those who meet all of the following conditions
- •SRI score of 50 points or more and 115 points or less
- •PSQI score of 5 or higher
- •TST confirmed by sleep diary is 6.5 hours or less (3 or more days within the last 1 week)
- •? SL confirmed by sleep diary is 30 minutes or more (3 or more days within the last 1 week)
- •3) Agree to participate in this human clinical trial and complete a written informed consent form before the start of the human clinical trial.
排除标准
- •1) Currently being treated for serious cardiovascular, immune, gastrointestinal/liver and biliary, renal and urinary, neurological, musculoskeletal, psychiatric, infectious, or malignant diseases or conditions
- •2) Napping for at least 1 hour 3 or more times per week
- •3) Those with an ISI score of 22 or more
- •4) Have conditions and factors that may interfere with sleep, such as nocturia or frequent urination
- •5) Those whose usual bedtime is outside of 9 PM to 1 AM and wake-up time is outside of 5 AM to 10 AM.
- •6) Those who are hospitalized, receiving medication, or undergoing rehabilitation for alcohol use or related disorders.
- •7) Those who are currently being treated for major depressive disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, etc. according to DSM-5, or who meet the following criteria
- •PHQ-9 score of 15 points or more as of Visit 1
- •8) Those who are suffering from or have a history of mental illness such as schizophrenia, bipolar disorder, etc.
- •9) Those with diseases accompanied by cognitive decline such as dementia (DSM-5 criteria), Parkinson's disease, etc.
- •10) Inability to perform polysomnography (claustrophobia, insertion of magnetic electronic devices into the body, etc.)
- •11) Receiving treatment or therapy (such as a positive airway pressure machine) for sleep disorders (insomnia, narcolepsy, obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder, etc.) within 1 month (30 days) of Visit 1 or meeting the following criteria
- •Those with a STOP-Bang score of 5 or more
- •12) Body mass index (BMI) is less than 18.5 kg/m2 or more than 35 kg/m2.
- •13) Individuals who are experiencing withdrawal from alcohol, tobacco, etc.
- •14) High caffeine intake {more than 400 mg (4 cups/day)
- •15) Consumers of alcohol more than 210 g/week for men and 140 g/week for women
- •16) Those who have irregular sleep habits such as shift work and night work within 1 month of visit 1
- •17) Acute stress (death in the family, incarceration, divorce, separation, debt, runaway, derailment, infidelity, business failure, major illness, remarriage, etc.) within 1 month of visit 1
- •18) Visited a place with a time difference within 1 month of visit1
- •19) Taking oral steroids or corticosteroids within 1 month prior to visit 1
- •20) Use of medications that affect sleep (anticonvulsants, antidepressants, anxiolytics, sleeping pills, antipsychotics, beta-blockers, bronchodilators, stimulants, melatonin, antihistamines, etc.) within 1 month of Visit 1
- •21) Consumption of dietary supplements related to sleep improvement within 1 month prior to Visit 1
- •22) Use of antibiotics or antispasmodics within 2 weeks prior to Visit 1
- •23) Consumption of probiotics, prebiotics, or probiotic products on a continuous basis (4 or more times per week) within 2 weeks prior to Visit 1
- •24) Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg, as measured after 10 minutes of rest in human subjects)
- •25) Uncontrolled diabetes (fasting blood glucose greater than or equal to 180 mg/dL or new initiation of medication for diabetes within 3 months of Visit 1)
- •26) TSH less than or equal to 0.1 µIU/mL or greater than or equal to 10 µIU/mL
- •27) Creatinine greater than or equal to 2 times the upper limit of normal for the site
- •28) AST (GOT) or ALT (GPT) greater than or equal to 3 times the upper limit of normal for the site.
- •29) Participation in anothe
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