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Completed

NCT Number: NCT04857021

Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

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

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Key information

Conditions

Sleep Disturbance Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyunghee University Hospital at Gangdong

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GABA

Dietary Supplement

oral administration of GABA capsule once daily before sleep

Other names: Lactobacillus brevis-fermented

Placebo

Dietary Supplement

oral administration of placebo capsule once daily before sleep

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2021
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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