CompletedNot Applicable

Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

South Korea60 participantsStarted 2019-04-14

Plain-language summary

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

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of total sleep time of polysomnography

Timeframe: Baseline, Week 2

Change of sleep latency of polysomnography

Timeframe: Baseline, Week 2

Change of sleep efficiency of polysomnography

Timeframe: Baseline, Week 2

Change of NonREM stage3 of polysomnography

Timeframe: Baseline, Week 2

Change of total wake time of polysomnography

Timeframe: Baseline, Week 2

Change of wake after sleep onset of polysomnography

Timeframe: Baseline, Week 2

Trial details

NCT IDNCT04857021

SponsorAmorepacific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-15

View on ClinicalTrials.gov More Sleep Disturbance trials

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change of total sleep time of polysomnography

Timeframe: Baseline, Week 2

Change of sleep latency of polysomnography

Timeframe: Baseline, Week 2

Change of sleep efficiency of polysomnography

Timeframe: Baseline, Week 2

Change of NonREM stage3 of polysomnography

Timeframe: Baseline, Week 2

Change of total wake time of polysomnography

Timeframe: Baseline, Week 2

Change of wake after sleep onset of polysomnography

Timeframe: Baseline, Week 2