Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-29 @ 12:15 AM
Study NCT ID:
NCT06226259
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement Effects of Gamma Aminobutyric Acid（GABA） Supplementation on Treatment of Children With Insomnia
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Study Overview
Official Title:
Improvement Effects of Gamma Aminobutyric Acid（GABA） Supplementation on Treatment of Children With Insomnia, A Randomized, Placebo-controlled, Single-center, Intervention Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Children aged 6-12 years with insomnia will be randomly assigned to GABA supplement group and placebo group in a 1:1 ratio. Participants will be provided with corresponding interventions. The experiment group was given a common food GABA supplement already on the market, with 100 mg of GABA in the unit package. The placebo group replaced the equivalent amount of GABA with a placebo component of starch. Placebo and GABA supplement are identical in appearance to guarantee blindness. Subjects will be followed up at baseline and 2 weeks after taking the test supplementary GABA to assess its effect on symptoms of insomnia, psychological and emotional status, and as well as related brain functions.
All questionnaires will be filled out by the primary caregivers, and the physical examination data will be measured at Shanghai Children's Medical Center. Information on insomnia diagnosis, disease classification, current treatment, and comorbidities will be obtained from daily medical visit records.
This study was a randomized double-blind controlled trial. All participants in the study will be divided into two groups: GABA supplement in the intervention group and placebo in the control group. Both groups will be provided education of sleep hygiene. Participants should take GABA supplements or placebo once daily before sleep for 14 days. The primary endpoint is the change in sleep onset latency (SOL) from baseline at two weeks after the trial as assessed by sleep dairy and actigraphy. Secondary assessment indicators: Total sleep time（TST）; Sleep efficiency(SE); Wake after sleep onset(WASO); Time in bed(TIB); Children's Sleep Habits Questionnaire(CSHQ) . Changes of children's emotional and cognitive functions before and after intervention will be assessed using functional near-infrared spectroscopy（fNIRS） and relevant psychological scales . Adverse events(AE) will be closely monitored throughout the study.
All questionnaires will be filled out by the primary caregivers, and the physical examination data will be measured at Shanghai Children's Medical Center. Information on insomnia diagnosis, disease classification, current treatment, and comorbidities will be obtained from daily medical visit records.
This study was a randomized double-blind controlled trial. All participants in the study will be divided into two groups: GABA supplement in the intervention group and placebo in the control group. Both groups will be provided education of sleep hygiene. Participants should take GABA supplements or placebo once daily before sleep for 14 days. The primary endpoint is the change in sleep onset latency (SOL) from baseline at two weeks after the trial as assessed by sleep dairy and actigraphy. Secondary assessment indicators: Total sleep time（TST）; Sleep efficiency(SE); Wake after sleep onset(WASO); Time in bed(TIB); Children's Sleep Habits Questionnaire(CSHQ) . Changes of children's emotional and cognitive functions before and after intervention will be assessed using functional near-infrared spectroscopy（fNIRS） and relevant psychological scales . Adverse events(AE) will be closely monitored throughout the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: