RecruitingNot ApplicableNCT06226259

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

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

206 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

Insomnia

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.

Eligibility

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria6

Children （both male and female）age 6-12 years
Clearly diagnosed as chronic or short-term insomnia according International classification of sleep disorders-third edition（ICSD-3）
No hearing or vision impairment, able to follow simple instructions from clinicians or parents
Have not participated in any drug clinical trials within 3 months at the screening point
The child or family member has the ability to evaluate and fill in a sleep diary and operate an actigraphy
Sign informed consent

Exclusion Criteria10

Previously diagnosed and known to be associated with intellectual disability (IQ ≤ 70)
Clear diagnosis of anxiety disorder in the past
Clear diagnosis of depression
Suffering from serious cardiopulmonary and blood system diseases, low immune function, and physical diseases
Suffering from mental developmental disorders associated with sleep disturbance and major psychosis, including well-defined (autism spectrum disorder; Attention deficit hyperactivity disorder; Schizophrenia; Schizoaffective disorder; Bipolar disorder;Post-traumatic stress disorder; Compulsive disorder; Mental disorders caused by epilepsy etc.)
Suffering from other disorders associated with insomnia, including well-defined diagnoses (sleep apnea, periodic limb movement disorder, restless leg syndrome and nocturnal frontal lobe epilepsy, circadian dysrhythmia sleep disorder)
Use of drugs that affect sleep (e.g. sleeping pills, sedatives, antiasthmatics, melatonin, antihistamines)
Suffering from allergies or allergies to milk proteins and lactose intolerance
The researchers think that is not suitable for other conditions (for example: nearly three months in other clinical research and are taking any other intervening drugs)
Informed consent could not be obtained