Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

Sleep Disturbance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04857021
• Other study ID #: AP-PV-2018-01
• Status: Completed
• Phase: N/A
• Start date: April 14, 2019
• Est. completion date: June 15, 2021

Study information

• Verified date: June 2021
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Dietary Supplement:
• GABA
oral administration of GABA capsule once daily before sleep
• Placebo
oral administration of placebo capsule once daily before sleep

Locations

Country	Name	City	State
Korea, Republic of	Kyunghee University Hospital at Gangdong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of total sleep time of polysomnography	total sleep time(minutes)	Baseline, Week 2
Primary	Change of sleep latency of polysomnography	sleep latency(minutes)	Baseline, Week 2
Primary	Change of sleep efficiency of polysomnography	sleep efficiency(percent)	Baseline, Week 2
Primary	Change of NonREM stage3 of polysomnography	NonREM stage3(mintues)	Baseline, Week 2
Primary	Change of total wake time of polysomnography	total wake time(mintues)	Baseline, Week 2
Primary	Change of wake after sleep onset of polysomnography	wake after sleep onset(mintues)	Baseline, Week 2
Secondary	Change of Pittsburgh Sleep Quality Index	Change of Pittsburgh Sleep Quality Index(0-21), higher score means worse outcome	Baseline, Week 2
Secondary	Change of Insomnia Severity Index	Change of Insomnia Severity Index(0-28), higher score means worse outcome	Baseline, Week 2
Secondary	Change of Epworth sleepiness scale	Change of Epworth sleepiness scale(0-24), higher score means worse outcome	Baseline, Week 2
Secondary	Change of Fatigue Severity Scale	Change of Fatigue Severity Scale(9-63), higher score means worse outcome	Baseline, Week 2