Actively Recruiting
Improvement Effects of Gamma Aminobutyric Acid（GABA） Supplementation on Treatment of Children With Insomnia
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-06-20
206
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improvement Effects of Gamma Aminobutyric Acid（GABA） Supplementation on Treatment of Children With Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children (both male and female) aged 6 to 12 years
- Diagnosed with chronic or short-term insomnia according to International Classification of Sleep Disorders-third edition (ICSD-3)
- No hearing or vision impairment and able to follow simple instructions
- Have not participated in any drug clinical trials within the past 3 months
- Ability of child or family member to complete sleep diary and operate actigraphy
- Signed informed consent
You will not qualify if you...
- Diagnosed intellectual disability with IQ 64 70
- History of anxiety disorder
- History of depression
- Serious cardiopulmonary, blood system diseases, low immune function, or physical diseases
- Mental developmental disorders related to sleep disturbance or major psychosis (including autism spectrum disorder, ADHD, schizophrenia, schizoaffective disorder, bipolar disorder, PTSD, compulsive disorder, epilepsy-related mental disorders)
- Other disorders associated with insomnia (including sleep apnea, periodic limb movement disorder, restless leg syndrome, nocturnal frontal lobe epilepsy, circadian dysrhythmia sleep disorder)
- Use of medications affecting sleep (e.g., sleeping pills, sedatives, antiasthmatics, melatonin, antihistamines)
- Allergies to milk proteins or lactose intolerance
- Participation in other clinical research or use of other interventions within three months
- Unable to give informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
G
Guanghai wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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