Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and safety of dietary supplement GABA in subjects with mild, transient sleep disorder.

Detailed Description
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The subjects will take GABA or placebo capsule once daily before sleep for 14 days.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Study to Investigate the Sleep Quality Enhancing Effect and Safety of Lactobacillus-fermented GABA in Subjects With Mild, Transient Sleep Disorder

Conditions
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Sleep Disturbance

Intervention / Treatment
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* Dietary Supplement: GABA
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects older than 19 years old Who is experiencing mild, transient sleep disturbance (pittsburgh sleep quality index ≥ 5, Insomnia Severity Index ≥ 8) Who voluntarily agreed to participate in the study and signed an informed consent form. Exclusion Criteria: Who is suffering from severe sleep disorder including sleep disorders due to psychological or neurologic causes. Who has used sleeping pills or sleep related dietary supplements within 4 weeks before study participation Who is suffering from obstructive sleep apnea. Who has used or is expected to inevitably use prohibited concomitant medications during the study. Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives. Who has dosed other study medications within 30 days before screening. Who is determined ineligible for study participation by investigators for any other reasons.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GABA<br>Take GABA capsule once daily before sleep for 14 days. | Dietary Supplement: GABA<br>* oral administration of GABA capsule once daily before sleep<br>* Other names: Lactobacillus brevis-fermented;|
| Placebo Comparator: Placebo<br>Take placebo capsule once daily before sleep for 14 days. | Dietary Supplement: Placebo<br>* oral administration of placebo capsule once daily before sleep<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of total sleep time of polysomnography | total sleep time(minutes) | Baseline, Week 2 | 
| Change of sleep latency of polysomnography | sleep latency(minutes) | Baseline, Week 2 | 
| Change of sleep efficiency of polysomnography | sleep efficiency(percent) | Baseline, Week 2 | 
| Change of NonREM stage3 of polysomnography | NonREM stage3(mintues) | Baseline, Week 2 | 
| Change of total wake time of polysomnography | total wake time(mintues) | Baseline, Week 2 | 
| Change of wake after sleep onset of polysomnography | wake after sleep onset(mintues) | Baseline, Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pittsburgh Sleep Quality Index | Change of Pittsburgh Sleep Quality Index(0-21), higher score means worse outcome | Baseline, Week 2 | 
| Change of Insomnia Severity Index | Change of Insomnia Severity Index(0-28), higher score means worse outcome | Baseline, Week 2 | 
| Change of Epworth sleepiness scale | Change of Epworth sleepiness scale(0-24), higher score means worse outcome | Baseline, Week 2 | 
| Change of Fatigue Severity Scale | Change of Fatigue Severity Scale(9-63), higher score means worse outcome | Baseline, Week 2 |