Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

NCT04857021 | Completed

• 1 other identifier: AP-PV-2018-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (6)

• Change of total sleep time of polysomnography

  total sleep time(minutes)

  Baseline, Week 2

• Change of sleep latency of polysomnography

  sleep latency(minutes)

  Baseline, Week 2

• Change of sleep efficiency of polysomnography

  sleep efficiency(percent)

  Baseline, Week 2

• Change of NonREM stage3 of polysomnography

  NonREM stage3(mintues)

  Baseline, Week 2

• Change of total wake time of polysomnography

  total wake time(mintues)

  Baseline, Week 2

• Change of wake after sleep onset of polysomnography

  wake after sleep onset(mintues)

  Baseline, Week 2

Secondary Outcomes (4)

• Change of Pittsburgh Sleep Quality Index

  Baseline, Week 2

• Change of Insomnia Severity Index

  Baseline, Week 2

• Change of Epworth sleepiness scale

  Baseline, Week 2

• Change of Fatigue Severity Scale

  Baseline, Week 2

Study Arms (2)

GABA

ACTIVE COMPARATOR

Take GABA capsule once daily before sleep for 14 days.

Dietary Supplement: GABA

Placebo

PLACEBO COMPARATOR

Take placebo capsule once daily before sleep for 14 days.

Dietary Supplement: Placebo

Interventions

GABA DIETARY_SUPPLEMENT

oral administration of GABA capsule once daily before sleep

Also known as: Lactobacillus brevis-fermented

GABA

Placebo DIETARY_SUPPLEMENT

oral administration of placebo capsule once daily before sleep

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amorepacific Corporation: lead

Study Sites (1)

Kyunghee University Hospital at Gangdong

Seoul, South Korea

Location

MeSH Terms

Conditions

Parasomnias

Interventions

gamma-Aminobutyric Acid

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 23, 2021
• Study Start: April 14, 2019
• Primary Completion: February 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)