Sleep DisturbanceNCT04857021
Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA
A study testing GABA in people with Sleep Disturbance, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the efficacy and safety of dietary supplement GABA in subjects with mild, transient sleep disorder. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- GABA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Apr 2019to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The purpose of this study is to investigate the efficacy and safety of dietary supplement GABA in subjects with mild, transient sleep disorder.
Read the detailed description
The subjects will take GABA or placebo capsule once daily before sleep for 14 days.
- Conditions
- Sleep Disturbance
- Being tested
- GABA, Placebo
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GABADietary supplement
Also called Lactobacillus brevis-fermented
oral administration of GABA capsule once daily before sleep
PlaceboDietary supplement
oral administration of placebo capsule once daily before sleep
| Study group | Role | What they receive |
|---|---|---|
| GABA | Active comparator | Take GABA capsule once daily before sleep for 14 days. Receives: Dietary Supplement: GABA |
| Placebo | Placebo comparator | Take placebo capsule once daily before sleep for 14 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total sleep time of polysomnography
total sleep time(minutes)
Measured: Baseline, Week 2
Change of sleep latency of polysomnography
sleep latency(minutes)
Measured: Baseline, Week 2
Change of sleep efficiency of polysomnography
sleep efficiency(percent)
Measured: Baseline, Week 2
Change of NonREM stage3 of polysomnography
NonREM stage3(mintues)
Measured: Baseline, Week 2
Change of total wake time of polysomnography
total wake time(mintues)
Measured: Baseline, Week 2
Change of wake after sleep onset of polysomnography
wake after sleep onset(mintues)
Measured: Baseline, Week 2
Secondary outcomes (4)
Change of Pittsburgh Sleep Quality Index
Change of Pittsburgh Sleep Quality Index(0-21), higher score means worse outcome
Measured: Baseline, Week 2
Change of Insomnia Severity Index
Change of Insomnia Severity Index(0-28), higher score means worse outcome
Measured: Baseline, Week 2
Change of Epworth sleepiness scale
Change of Epworth sleepiness scale(0-24), higher score means worse outcome
Measured: Baseline, Week 2
Change of Fatigue Severity Scale
Change of Fatigue Severity Scale(9-63), higher score means worse outcome
Measured: Baseline, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start14 Apr 2019
- Primary completion15 Feb 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857021
- Sponsor's protocol ID
- AP-PV-2018-01
- Status last verified
- Jun 2021
- First submitted
- 14 Apr 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04857021
- Acronym / sponsor ID
- AP-PV-2018-01
- Conditions
- Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GABA | Active comparator | Dietary Supplement: GABATake GABA capsule once daily before sleep for 14 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTake placebo capsule once daily before sleep for 14 days. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GABAAlso: Lactobacillus brevis-fermentedoral administration of GABA capsule once daily before sleep | Dietary supplement | GABA |
| Placebooral administration of placebo capsule once daily before sleep | Dietary supplement | Placebo |
Primary outcome
Change of total sleep time of polysomnography
Time frame: Baseline, Week 2
total sleep time(minutes)
Change of sleep latency of polysomnography
Time frame: Baseline, Week 2
sleep latency(minutes)
Change of sleep efficiency of polysomnography
Time frame: Baseline, Week 2
sleep efficiency(percent)
Change of NonREM stage3 of polysomnography
Time frame: Baseline, Week 2
NonREM stage3(mintues)
Change of total wake time of polysomnography
Time frame: Baseline, Week 2
total wake time(mintues)
Change of wake after sleep onset of polysomnography
Time frame: Baseline, Week 2
wake after sleep onset(mintues)
4 secondary outcomes
Change of Pittsburgh Sleep Quality Index
Time frame: Baseline, Week 2
Change of Insomnia Severity Index
Time frame: Baseline, Week 2
Change of Epworth sleepiness scale
Time frame: Baseline, Week 2
Change of Fatigue Severity Scale
Time frame: Baseline, Week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GABA in people with Sleep Disturbance, run by Amorepacific Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of total sleep time of polysomnography (time frame: Baseline, Week 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.