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Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04857021
Recruitment Status : Completed
First Posted : April 23, 2021
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
Amorepacific Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Disturbance Dietary Supplement: GABA Dietary Supplement: Placebo Not Applicable

Detailed Description:
The subjects will take GABA or placebo capsule once daily before sleep for 14 days.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : April 14, 2019
Actual Primary Completion Date : February 15, 2021
Actual Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Change of total sleep time of polysomnography [ Time Frame: Baseline, Week 2 ]
    total sleep time(minutes)

  2. Change of sleep latency of polysomnography [ Time Frame: Baseline, Week 2 ]
    sleep latency(minutes)

  3. Change of sleep efficiency of polysomnography [ Time Frame: Baseline, Week 2 ]
    sleep efficiency(percent)

  4. Change of NonREM stage3 of polysomnography [ Time Frame: Baseline, Week 2 ]
    NonREM stage3(mintues)

  5. Change of total wake time of polysomnography [ Time Frame: Baseline, Week 2 ]
    total wake time(mintues)

  6. Change of wake after sleep onset of polysomnography [ Time Frame: Baseline, Week 2 ]
    wake after sleep onset(mintues)


Secondary Outcome Measures :
  1. Change of Pittsburgh Sleep Quality Index [ Time Frame: Baseline, Week 2 ]
    Change of Pittsburgh Sleep Quality Index(0-21), higher score means worse outcome

  2. Change of Insomnia Severity Index [ Time Frame: Baseline, Week 2 ]
    Change of Insomnia Severity Index(0-28), higher score means worse outcome

  3. Change of Epworth sleepiness scale [ Time Frame: Baseline, Week 2 ]
    Change of Epworth sleepiness scale(0-24), higher score means worse outcome

  4. Change of Fatigue Severity Scale [ Time Frame: Baseline, Week 2 ]
    Change of Fatigue Severity Scale(9-63), higher score means worse outcome


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857021


Locations
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Korea, Republic of
Kyunghee University Hospital at Gangdong
Seoul, Korea, Republic of
Sponsors and Collaborators
Amorepacific Corporation
More Information
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Responsible Party: Amorepacific Corporation
ClinicalTrials.gov Identifier: NCT04857021    
Other Study ID Numbers: AP-PV-2018-01
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders