Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

September 17, 2021 updated by: Amorepacific Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GABA
Take GABA capsule once daily before sleep for 14 days.
Dietary supplement: GABA
oral administration of GABA capsule once daily before sleep
Other Names:
  • Lactobacillus brevis-fermented
Placebo Comparator: Placebo
Take placebo capsule once daily before sleep for 14 days.
Dietary supplement: Placebo
oral administration of placebo capsule once daily before sleep

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amorepacific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2019

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP-PV-2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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