Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the efficacy and safety of dietary supplement GABA in subjects with mild, transient sleep disorder.
The subjects will take GABA or placebo capsule once daily before sleep for 14 days.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GABA | Active Comparator | Take GABA capsule once daily before sleep for 14 days. |
|
| Placebo | Placebo Comparator | Take placebo capsule once daily before sleep for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GABA | Dietary Supplement | oral administration of GABA capsule once daily before sleep |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyunghee University Hospital at Gangdong | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| ID | Term |
|---|---|
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | oral administration of placebo capsule once daily before sleep |
|
| 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 |
| D009930 |
| Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |