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Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

Primary Purpose

Sleep Disturbance

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GABA

Placebo

About this trial

This is an interventional other trial for Sleep Disturbance

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kyunghee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

GABA

Placebo

Arm Description

Take GABA capsule once daily before sleep for 14 days.

Take placebo capsule once daily before sleep for 14 days.

Outcomes

Primary Outcome Measures

Change of total sleep time of polysomnography

total sleep time(minutes)

Change of sleep latency of polysomnography

sleep latency(minutes)

Change of sleep efficiency of polysomnography

sleep efficiency(percent)

Change of NonREM stage3 of polysomnography

NonREM stage3(mintues)

Change of total wake time of polysomnography

total wake time(mintues)

Change of wake after sleep onset of polysomnography

wake after sleep onset(mintues)

Secondary Outcome Measures

Change of Pittsburgh Sleep Quality Index

Change of Pittsburgh Sleep Quality Index(0-21), higher score means worse outcome

Change of Insomnia Severity Index

Change of Insomnia Severity Index(0-28), higher score means worse outcome

Change of Epworth sleepiness scale

Change of Epworth sleepiness scale(0-24), higher score means worse outcome

Change of Fatigue Severity Scale

Change of Fatigue Severity Scale(9-63), higher score means worse outcome

Full Information

NCT ID

NCT04857021

First Posted

April 14, 2021

Last Updated

September 17, 2021

Sponsor

Amorepacific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04857021

Brief Title

Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

April 14, 2019 (Actual)

Primary Completion Date

February 15, 2021 (Actual)

Study Completion Date

June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amorepacific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disturbance

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GABA

Arm Type

Active Comparator

Arm Description

Take GABA capsule once daily before sleep for 14 days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Take placebo capsule once daily before sleep for 14 days.

Intervention Type

Dietary Supplement

Intervention Name(s)

GABA

Other Intervention Name(s)

Lactobacillus brevis-fermented

Intervention Description

oral administration of GABA capsule once daily before sleep

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

oral administration of placebo capsule once daily before sleep

Primary Outcome Measure Information:

Title

Change of total sleep time of polysomnography

Description

total sleep time(minutes)

Time Frame

Baseline, Week 2

Title

Change of sleep latency of polysomnography

Description

sleep latency(minutes)

Time Frame

Baseline, Week 2

Title

Change of sleep efficiency of polysomnography

Description

sleep efficiency(percent)

Time Frame

Baseline, Week 2

Title

Change of NonREM stage3 of polysomnography

Description

NonREM stage3(mintues)

Time Frame

Baseline, Week 2

Title

Change of total wake time of polysomnography

Description

total wake time(mintues)

Time Frame

Baseline, Week 2

Title

Change of wake after sleep onset of polysomnography

Description

wake after sleep onset(mintues)

Time Frame

Baseline, Week 2

Secondary Outcome Measure Information:

Title

Change of Pittsburgh Sleep Quality Index

Description

Change of Pittsburgh Sleep Quality Index(0-21), higher score means worse outcome

Time Frame

Baseline, Week 2

Title

Change of Insomnia Severity Index

Description

Change of Insomnia Severity Index(0-28), higher score means worse outcome

Time Frame

Baseline, Week 2

Title

Change of Epworth sleepiness scale

Description

Change of Epworth sleepiness scale(0-24), higher score means worse outcome

Time Frame

Baseline, Week 2

Title

Change of Fatigue Severity Scale

Description

Change of Fatigue Severity Scale(9-63), higher score means worse outcome

Time Frame

Baseline, Week 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Kyunghee University Hospital at Gangdong

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

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