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

NCT06226259 | Recruiting

• 1 other identifier: LY202330154
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Change of sleep onset latency (SOL) of actigraphy

  sleep onset latency (minutes)

  Baseline, Week 2

Secondary Outcomes (12)

• Change of total sleep time （TST）of actigraphy

  Baseline, Week 2

• Change of sleep efficiency(SE) of actigraphy

  Baseline, Week 2

• Change of wake-time after sleep onset (WASO)of actigraphy

  Baseline, Week 2

• Change of time in bed (TIB) of actigraphy

  Baseline, Week 2

• Children's Sleep Habits Questionnaire （CSHQ）

  Baseline, Week 2

Other Outcomes (5)

• Parental emotion:Generalized Anxiety Disorder-7(GAD-7)

  Baseline, Week 2

• Parental emotion:Patient Health Questionnaire-9(PHQ-9)

  Baseline, Week 2

• Parental life quality

  Baseline, Week 2

Study Arms (2)

GABA supplement group

EXPERIMENTAL

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.

Dietary Supplement: GABA supplement

placebo group

PLACEBO COMPARATOR

Placebo ,Take orally every night before sleep for 14 days.

Dietary Supplement: placebo

Interventions

GABA supplement DIETARY_SUPPLEMENT

Oral administration of GABA supplement once daily before sleep for 14 days.

GABA supplement group

placebo DIETARY_SUPPLEMENT

Oral administration of placebo once daily before sleep for 14 days.

placebo group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Guanghai wang

CONTACT

18817563577; wang-guanghai@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator，Professor

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 26, 2024
• Study Start: March 25, 2024
• Primary Completion: November 12, 2025
• Study Completion: December 22, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

CN (1)