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NCT06226259Not yet recruiting

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

Improvement Effects of Gamma Aminobutyric Acid(GABA) Supplementation on Treatment of Children With Insomnia, A Randomized, Placebo-controlled, Single-center, Intervention Study
Shanghai Jiao Tong University School of MedicineClinicalTrials.govdietary supplement
Study focus
Disease/Condition
Insomnia
Drug/Device/Intervention
GABA supplement
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Shanghai Jiao Tong University School of Medicine
Timeline & enrollment
Phase
N/A
Start date
Feb 25, 2024
End date
Dec 22, 2025
Enrollment
206 participants
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
Nonorganic insomniaDisorders of initiating and maintaining sleep [insomnias]Sleep disordersSleep disorder, unspecifiedOther sleep disorders
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06226259
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06226259 through Pure Global AI's free database. This phase not specified trial is sponsored by Shanghai Jiao Tong University School of Medicine and is currently Not yet recruiting. The study focuses on Insomnia. Target enrollment is 206 participants.

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