GABA supplementation for treating insomnia in children

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

This study is testing if giving GABA supplements can help children aged 6-12 with insomnia sleep better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06226259 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Gamma Aminobutyric Acid (GABA) supplementation on children aged 6-12 years diagnosed with insomnia. A total of 206 participants will be randomly assigned to receive either a daily dose of 100mg GABA or a placebo for two weeks. The study aims to assess changes in sleep onset latency and other sleep parameters through caregiver-reported questionnaires and actigraphy. Both groups will receive education on sleep hygiene to ensure consistency in managing sleep behaviors.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6-12 years who have been diagnosed with chronic or short-term insomnia.

Not a fit: Patients with intellectual disabilities, anxiety disorders, depression, or serious physical health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safe and effective non-pharmacological treatment option for children suffering from insomnia.

How similar studies have performed: Previous studies have shown that GABA supplementation can improve insomnia in adults, but this approach in children is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Guanghai wang

Conditions Insomnia