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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep diary;Pittsburgh Sleep Quality Index;Polysomnography;Insomnia severity scale score;Actigraphy;Epworth Sleepiness Scale;Beck depression inventory-?;State trait anxiety inventory;Biomarker(BDNF, IL-6, Orexin A, Serotonin, Melatonin);fecal microbiota

Secondary Outcome Measures

Name	Time	Method
Adverse event;Clinical laboratory tests including hematologic, blood chemistry, and urinalysis;Vital signs, including blood pressure, pulse, and anthropometric measurements such as body weight;Electrocardiogram