Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

Not Applicable

Completed

• Conditions: Sleep Disturbance
• Interventions: Dietary Supplement: GABA; Dietary Supplement: Placebo

• Registration Number: NCT04857021
• Lead Sponsor: Amorepacific Corporation

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.

Study Timeline

• Study Start: 2019-04-14
• Primary Completion: 2021-02-15
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-23
• Status Verified: 2021-06
• Study Completion: 2021-06-15
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GABA	GABA	Take GABA capsule once daily before sleep for 14 days.
Placebo	Placebo	Take placebo capsule once daily before sleep for 14 days.

Primary Outcome Measures

Name	Time	Method
Change of wake after sleep onset of polysomnography	Baseline, Week 2	wake after sleep onset(mintues)
Change of total sleep time of polysomnography	Baseline, Week 2	total sleep time(minutes)
Change of sleep efficiency of polysomnography	Baseline, Week 2	sleep efficiency(percent)
Change of sleep latency of polysomnography	Baseline, Week 2	sleep latency(minutes)
Change of NonREM stage3 of polysomnography	Baseline, Week 2	NonREM stage3(mintues)
Change of total wake time of polysomnography	Baseline, Week 2	total wake time(mintues)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyunghee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of