Improvement Effects of Gamma Aminobutyric Acid(GABA) Supplementation on Treatment of Children With Insomnia, A Randomized, Placebo-controlled, Single-center, Intervention Study

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
RECRUITING
Shanghai
Contact Information
Primary
Guanghai wang
wang-guanghai@163.com
18817563577
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2025-12-22
Participants
Target number of participants: 206
Treatments
Experimental: GABA supplement group
The experimental group was given a kind of GABA supplement already on the market, with 100mg of GABA in the unit package.~Take orally every night before sleep for 14 days.
Placebo_comparator: placebo group
Placebo ,Take orally every night before sleep for 14 days.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov