Improving sleep in children with neurodevelopmental disorders using pulsed current stimulation
Improving Sleep of Children With Neurodevelopmental Disorders: A Prospective, Randomised Controlled Trial Using Pulsed Current Stimulation Versus Melatonin
NA · KK Women's and Children's Hospital · NCT06236191
This study is testing if a new method called pulsed current stimulation can help children with neurodevelopmental disorders sleep better than the usual treatment with Melatonin.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 4 Years to 16 Years |
| Sex | All |
| Sponsor | KK Women's and Children's Hospital (other gov) |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06236191 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of transcranial pulsed current stimulation (tPCS) in increasing total sleep time in children aged 4-16 with neurodevelopmental disorders, compared to the commonly used treatment of Melatonin. The study is designed as a single-center, randomized controlled crossover trial involving 40 participants. It aims to address the issue of poor sleep quality in children with conditions like cerebral palsy and autism, which can exacerbate their symptoms and affect their quality of life. The trial will assess sleep improvements through objective measurements and questionnaires.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4-16 diagnosed with neurodevelopmental disorders such as cerebral palsy or autism, who experience significant sleep disturbances.
Not a fit: Patients with uncontrolled epilepsy, certain mental health disorders, or those currently using specific medications that affect sleep 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 improving sleep in children with neurodevelopmental disorders.
How similar studies have performed: While non-invasive brain stimulation has shown promise in adult populations, this specific application of tPCS in children with neurodevelopmental disorders is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Singapore
- KKWCH — Singapore, Singapore (RECRUITING)
Study contacts
- Principal investigator: Zhi Min Ng — KK Women's and Children's Hospital
- Study coordinator: Zhi Min Ng, MBBS, MRCPCH
- Email: ng.zhi.min@singhealth.com.sg
- Phone: +65-6394 8975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Insomnia, Neurodevelopmental Disorders