Sleep Disturbance
Conditions
Brief summary
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
The subjects will take GABA or placebo capsule once daily before sleep for 14 days.
Interventions
DIETARY_SUPPLEMENTGABA
oral administration of GABA capsule once daily before sleep
DIETARY_SUPPLEMENTPlacebo
oral administration of placebo capsule once daily before sleep
Sponsors
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of wake after sleep onset of polysomnography | Baseline, Week 2 | wake after sleep onset(mintues) |
| Change of sleep latency of polysomnography | Baseline, Week 2 | sleep latency(minutes) |
| Change of sleep efficiency of polysomnography | Baseline, Week 2 | sleep efficiency(percent) |
| Change of NonREM stage3 of polysomnography | Baseline, Week 2 | NonREM stage3(mintues) |
| Change of total wake time of polysomnography | Baseline, Week 2 | total wake time(mintues) |
| Change of total sleep time of polysomnography | Baseline, Week 2 | total sleep time(minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Insomnia Severity Index | Baseline, Week 2 | Change of Insomnia Severity Index(0-28), higher score means worse outcome |
| Change of Epworth sleepiness scale | Baseline, Week 2 | Change of Epworth sleepiness scale(0-24), higher score means worse outcome |
| Change of Fatigue Severity Scale | Baseline, Week 2 | Change of Fatigue Severity Scale(9-63), higher score means worse outcome |
| Change of Pittsburgh Sleep Quality Index | Baseline, Week 2 | Change of Pittsburgh Sleep Quality Index(0-21), higher score means worse outcome |
Countries
South Korea
Outcome results
None listed