InsomniaNCT06236191
Improving Sleep of Children With Neurodevelopmental Disorders: Pulsed Current Stimulation Versus Melatonin
A study testing transcranial pulsed current stimulation and Melatonin in people with Insomnia and Neurodevelopmental Disorders, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
This is a prospective, randomised controlled trial that evaluates whether transcranial pulsed current stimulation increased total sleep time in children with neuroevelopmental disorder, compared to Melatonin Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Insomnia, Neurodevelopmental Disorders
- What is being tested?
- transcranial pulsed current stimulation and Melatonin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Jul 2023to 30 Sep 2024
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 4-16
- Neurodevelopmental disorder including cerebral palsy, autistic spectrum disorder, neurogenetic syndrome.
- Patients whose pre-intervention sleep questionnaire total score more than 46 and/or pre-intervention sleep questionnaire T-score more than 70 in any sleep domain
- Children agree to tPCS as per procedure and consent to the study, including need to shave hair at the site of stimulation at the occiput
- Parents/carers agree to tPCS as per visit schedule and procedure
- Medical practitioner's approval
Who cannot join
- History of uncontrolled epileptic disorders and seizures, brain tumours or trauma and mental diseases, substance abuse or dependence, use of benzodiazepines, neuroleptic, serotonin or dopaminergic drugs, presence of metal/ electronic implant in brain/ body eg. shunt, cochlear implant, pacemaker or defibrillator, untreated known obstructive sleep apnoea or another previously diagnosed sleep disorder, and current involvement in other tDCS or rTMS trials. Patients with history of drug allergy to Melatonin will also be excluded.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
KKWCH
Singapore, 229899
Zhi Min Ng, MBBS, ng.zhi.min@singhealth.com.sg
About this study
Official title: Improving Sleep of Children With Neurodevelopmental Disorders: A Prospective, Randomised Controlled Trial Using Pulsed Current Stimulation Versus Melatonin
This is a prospective, randomised controlled trial that evaluates whether transcranial pulsed current stimulation increased total sleep time in children with neuroevelopmental disorder, compared to Melatonin
Read the detailed description
Background: Children with neurodevelopmental disorder such as cerebral palsy (CP) and autistic spectrum disorder have poor sleep. Poor sleep in these children may lead to worsening spasticity, increased caregiver burden and poorer quality of life. Use of Melatonin is a common treatment for sleep but it is not helpful in sleep maintenance. More sedating pharmacological options have side-effects if given long-term. A safe and non-invasive intervention that can improve sleep in children with neurodevelopmental disorder is needed. In recent years, non-invasive brain stimulation such as transcranial electrical stimulation (TES) has emerged as a potential treatment to improve sleep in adult patients with major depressive disorders, bipolar disorders, migraine and Parkinson's disease. Transcranial pulsed current stimulation (tPCS) is a form of TES that has increasingly gained attention as a novel safe and cost-effective treatment modality for spasticity in children with CP and for improvement of gait in adults with Parkinson's Disease.
Hypothesis: tPCS is effective in improving total sleep time (TST) in children with neurodevelopmental disorder.
Aim: We aim to objectively evaluate whether tPCS can increase TST in children with neurodevelopmental disorder, compared to Melatonin.
Methodology and Analytical approach: Based on 80%power, alpha 0.05 and 20%drop-out rate, this is a single centre randomized control, crossover trial using Balaam's design that enrols 40 children with neurodevelopmental disorder: Patients will be treated with home-based tPCSor Melatonin over 8 weeks. All patients will do sleep actigraphy and sleep questionnaire using the Sleep Disturbance Scale for Children at baseline and at the end of trial.
Clinical Significance: tPCS could serve as a potential alternative for pharmacotherapy in treatment of insomnia in children with neurodevelopmental disorders. This could change clinical practice and improve quality of care for these children.
- Conditions
- Insomnia, Neurodevelopmental Disorders
- Being tested
- transcranial pulsed current stimulation, Melatonin
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial pulsed current stimulationDevice
A form of transcranial electrical stimulation that delivers unidirectional monophasic rectangular pulses of current.
MelatoninDrug
Melatonin
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group is transcranial pulse electrical stimulation Receives: Device: transcranial pulsed current stimulation |
| Comparator | Active comparator | comparator is Melatonin Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time (TST)
Improvement in TST; the higher the TST the better
Measured: 4 weeks
Secondary outcomes (4)
Sleep latency (SL)
Reduction in sleep latency (min); the lower the sleep latency the better
Measured: 4 weeks
Sleep efficiency (SE)
Increase in sleep efficiency (%); the higher the sleep efficiency the better
Measured: 4 weeks
wake after sleep onset (WASO)
Reduction in WASO; the lower the WASO the better
Measured: 4 weeks
Total score in sleep questionnaire
Reduction in total score in sleep questionnaire; max score 130 minimum score 26; the lower the better
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start24 Jul 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Sep 2024 (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 KK Women's and Children's HospitalThe 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
- Crossover
- Model description
- Crossover trial using Balaam's design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ng Zhi Min, KK Women's and Children's Hospital
- Investigators
- Zhi Min Ng, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236191
- Sponsor's protocol ID
- 2022/2216
- Status last verified
- Jan 2024
- First submitted
- 31 Jul 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sleep data including TST, SL, SE, WASO can be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep of Children With Neurodevelopmental Disorders: A Prospective, Randomised Controlled Trial Using Pulsed Current Stimulation Versus Melatonin
- ClinicalTrials.gov ID
- NCT06236191
- Acronym / sponsor ID
- 2022/2216
- Conditions
- Insomnia, Neurodevelopmental Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 1 Feb 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.
This is a prospective, randomised controlled trial that evaluates whether transcranial pulsed current stimulation increased total sleep time in children with neuroevelopmental disorder, compared to Melatonin
Detailed description
Background: Children with neurodevelopmental disorder such as cerebral palsy (CP) and autistic spectrum disorder have poor sleep. Poor sleep in these children may lead to worsening spasticity, increased caregiver burden and poorer quality of life. Use of Melatonin is a common treatment for sleep but it is not helpful in sleep maintenance. More sedating pharmacological options have side-effects if given long-term. A safe and non-invasive intervention that can improve sleep in children with neurodevelopmental disorder is needed. In recent years, non-invasive brain stimulation such as transcranial electrical stimulation (TES) has emerged as a potential treatment to improve sleep in adult patients with major depressive disorders, bipolar disorders, migraine and Parkinson's disease. Transcranial pulsed current stimulation (tPCS) is a form of TES that has increasingly gained attention as a novel safe and cost-effective treatment modality for spasticity in children with CP and for improvement of gait in adults with Parkinson's Disease.
Hypothesis: tPCS is effective in improving total sleep time (TST) in children with neurodevelopmental disorder.
Aim: We aim to objectively evaluate whether tPCS can increase TST in children with neurodevelopmental disorder, compared to Melatonin.
Methodology and Analytical approach: Based on 80%power, alpha 0.05 and 20%drop-out rate, this is a single centre randomized control, crossover trial using Balaam's design that enrols 40 children with neurodevelopmental disorder: Patients will be treated with home-based tPCSor Melatonin over 8 weeks. All patients will do sleep actigraphy and sleep questionnaire using the Sleep Disturbance Scale for Children at baseline and at the end of trial.
Clinical Significance: tPCS could serve as a potential alternative for pharmacotherapy in treatment of insomnia in children with neurodevelopmental disorders. This could change clinical practice and improve quality of care for these children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover trial using Balaam's design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: transcranial pulsed current stimulationIntervention group is transcranial pulse electrical stimulation |
| Comparator | Active comparator | Drug: Melatonincomparator is Melatonin |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 4-16
- Neurodevelopmental disorder including cerebral palsy, autistic spectrum disorder, neurogenetic syndrome.
- Patients whose pre-intervention sleep questionnaire total score more than 46 and/or pre-intervention sleep questionnaire T-score more than 70 in any sleep domain
- Children agree to tPCS as per procedure and consent to the study, including need to shave hair at the site of stimulation at the occiput
- Parents/carers agree to tPCS as per visit schedule and procedure
Key exclusion criteria (1 listed)
- History of uncontrolled epileptic disorders and seizures, brain tumours or trauma and mental diseases, substance abuse or dependence, use of benzodiazepines, neuroleptic, serotonin or dopaminergic drugs, presence of metal/ electronic implant in brain/ body eg. shunt, cochlear implant, pacemaker or defibrillator, untreated known obstructive sleep apnoea or another previously diagnosed sleep disorder, and current involvement in other tDCS or rTMS trials. Patients with history of drug allergy to Melatonin will also be excluded.
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 |
|---|---|---|
| transcranial pulsed current stimulationA form of transcranial electrical stimulation that delivers unidirectional monophasic rectangular pulses of current. | Device | Intervention |
| MelatoninMelatonin | Drug | Comparator |
Primary outcome
Total sleep time (TST)
Time frame: 4 weeks
Improvement in TST; the higher the TST the better
4 secondary outcomes
Sleep latency (SL)
Time frame: 4 weeks
Sleep efficiency (SE)
Time frame: 4 weeks
wake after sleep onset (WASO)
Time frame: 4 weeks
Total score in sleep questionnaire
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No. Sleep data including TST, SL, SE, WASO can be shared
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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.
Zhi Min Ng principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial pulsed current stimulation and Melatonin in people with Insomnia and Neurodevelopmental Disorders, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 1 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 1 Feb 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 Singapore. 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. 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 Zhi Min Ng, MBBS, MRCPCH (+65-6394 8975, ng.zhi.min@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time (TST) (time frame: 4 weeks). 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 1 Feb 2024.