InsomniaNCT06226259
Improvement Effects of Gamma Aminobutyric Acid（GABA） Supplementation on Treatment of Children With Insomnia
A study testing GABA supplement in people with Insomnia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Insomnia
- What is being tested?
- GABA supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2024to 22 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Guang Hai Wang, Docter
About this study
Official title: Improvement Effects of Gamma Aminobutyric Acid（GABA） Supplementation on Treatment of Children With Insomnia, A Randomized, Placebo-controlled, Single-center, Intervention Study
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- GABA supplement, placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GABA supplementDietary supplement
Oral administration of GABA supplement once daily before sleep for 14 days.
placeboDietary supplement
Oral administration of placebo once daily before sleep for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: GABA supplement |
| placebo group | Placebo comparator | Placebo ,Take orally every night before sleep for 14 days. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of sleep onset latency (SOL) of actigraphy
sleep onset latency (minutes)
Measured: Baseline, Week 2
Secondary outcomes (12)
Change of total sleep time （TST）of actigraphy
total sleep time(minutes)
Measured: Baseline, Week 2
Change of sleep efficiency(SE) of actigraphy
sleep efficiency (%)
Measured: Baseline, Week 2
Change of wake-time after sleep onset (WASO)of actigraphy
wake-time after sleep onset (minutes)
Measured: Baseline, Week 2
Change of time in bed (TIB) of actigraphy
time in bed (minutes)
Measured: Baseline, Week 2
Children's Sleep Habits Questionnaire （CSHQ）
A quantitative scale used to assess sleep habits in children,the CSHQ consists of 33 items. The instrument evaluates the child's sleep based on behavior within eight different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness.
Each item can be rated 1 -3，some items（item 1,2,3,10,11，26） need to be scored in reverse due to language representation. The cumulative total score is 33 - 66, The higher the score on the scale, the more poor the sleep habit.
Measured: Baseline, Week 2
insomnia symptoms:Athens Insomnia Scale (AIS)
The Athens Insomnia Scale (AIS) measures severity of insomnia symptoms. The cumulative total score is 0-24;The total scores of these questionnaires were interpreted as follows: normal (0-6), mild (7-9), moderate (10-15), severe (16-24)insomnia.
Measured: Baseline, Week 2
Child sleep diary
Parent-report child's sleep diary will be collected. Sleep parameters include bedtime, wake time, total sleep time, sleep onset latency, wake time after sleep onset, and the number of awakenings.
Measured: Baseline, Week 2
Griffith Empathy Measure Score
Griffith Empathy Measure (GEM ), is a 23-item parent-report measure of affective and cognitive empathy. The maximum score is 92. Higher scores reflect higher reported empathy.
Measured: Baseline, Week 2
Child emotion:The Chinese Version of Spence Children's Anxiety Scale-Short Version
This scale is used to assess anxiety in children which is a four-point Likert scale, from 0(never) to 3(always).The cumulative total score is 0-57 ,the higher the score, The more severe the anxiety.
Measured: Baseline, Week 2
Child emotion:Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
CES-DC is a self-rated depression questionnaire composed of 20 self-rated items with a total score ranging from 0 to 60 points, the higher the score, the higher the level of depression. The cutoff is 15 , scores above 15 indicating that depressive symptoms have a significant standard.
Measured: Baseline, Week 2
Executive Function
Behavior Rating Inventory of Executive Function(BRIEF) is designed to assess executive function behaviors of children and adolescents aged 5-18 years in the home and school environments. It includes 86 items which divided 8 dimensions. The score will be converted to T score.When the Global Executive Composite or one of the 8 dimensions T score come to 65,impaired executive function should be considered.Higher scores represent poorer executive function.
Measured: Baseline, Week 2
Child neuro-changes
The functional near-infrared spectroscopy (fNIRS) can collect the oxygenated hemoglobin and deoxyhemoglobin during brain activity.
Measured: Baseline, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start25 Mar 2024
- Primary completion12 Nov 2025 (estimated)
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guanghai Wang, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226259
- Sponsor's protocol ID
- LY202330154
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement Effects of Gamma Aminobutyric Acid（GABA） Supplementation on Treatment of Children With Insomnia, A Randomized, Placebo-controlled, Single-center, Intervention Study
- ClinicalTrials.gov ID
- NCT06226259
- Acronym / sponsor ID
- LY202330154
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 12 Nov 2025 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GABA supplement group | Experimental | Dietary Supplement: GABA supplementThe 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 group | Placebo comparator | Dietary Supplement: placeboPlacebo ,Take orally every night before sleep for 14 days. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GABA supplementOral administration of GABA supplement once daily before sleep for 14 days. | Dietary supplement | GABA supplement group |
| placeboOral administration of placebo once daily before sleep for 14 days. | Dietary supplement | placebo group |
Primary outcome
Change of sleep onset latency (SOL) of actigraphy
Time frame: Baseline, Week 2
sleep onset latency (minutes)
12 secondary outcomes
Change of total sleep time （TST）of actigraphy
Time frame: Baseline, Week 2
Change of sleep efficiency(SE) of actigraphy
Time frame: Baseline, Week 2
Change of wake-time after sleep onset (WASO)of actigraphy
Time frame: Baseline, Week 2
Change of time in bed (TIB) of actigraphy
Time frame: Baseline, Week 2
Children's Sleep Habits Questionnaire （CSHQ）
Time frame: Baseline, Week 2
insomnia symptoms:Athens Insomnia Scale (AIS)
Time frame: Baseline, Week 2
Child sleep diary
Time frame: Baseline, Week 2
Griffith Empathy Measure Score
Time frame: Baseline, Week 2
Child emotion:The Chinese Version of Spence Children's Anxiety Scale-Short Version
Time frame: Baseline, Week 2
Child emotion:Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Time frame: Baseline, Week 2
Executive Function
Time frame: Baseline, Week 2
Child neuro-changes
Time frame: Baseline, Week 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GABA supplement in people with Insomnia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guanghai wang (18817563577, wang-guanghai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of sleep onset latency (SOL) of actigraphy (time frame: Baseline, Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.