Improvement Effects of Gamma Aminobutyric Acid（GABA） Supplementation on Treatment of Children With Insomnia - Trial NCT06226259

Timeline & Enrollment

Primary Outcome

Change of sleep onset latency (SOL) of actigraphy

Summary

Around 20% of children worldwide suffer from insomnia. There are no approved drugs available
 for treating insomnia in children, and there may be treatment-related side effects. The Gamma
 aminobutyric Acid (GABA) is a neurotransmitter widely present in the brain, and GABA
 extracted by industry is a common food supplement. Previous studies indicate that oral GABA
 supplement can improve adult insomnia, and has the potential to reduce blood pressure,
 relieve stress and other effects. At present, there are few studies using oral GABA to
 improve insomnia in children. The purpose of the study is to explore the effects of oral GABA
 supplement on symptoms of insomnia (short - or long-term insomnia) in children. In this
 study, 206 children aged 6-12 years with a diagnosis of insomnia will be randomly assigned to
 receive GABA supplement of 100mg/ day or placebo for 2 weeks. Subjective and objective sleep
 parameters such as sleep onset latency (SOL) were measured with sleep questionnaires, diary,
 and actigraphy at baseline and 2 weeks later, while emotional/behavioral problems, and
 cognitive ability will be measured with parent-reported questionnaires. Also, related brain
 function was assessed with functional near-infrared spectroscopy (fNIRS). This study can
 provide more reference for the application of GABA in children with insomnia as a
 complementary and alternative therapy, and clarify the mechanism of action of GABA on
 insomnia.

ICD-10 Classifications