NCT06236191

Improving Sleep of Children With Neurodevelopmental Disorders: Pulsed Current Stimulation Versus Melatonin

Improving Sleep of Children With Neurodevelopmental Disorders: A Prospective, Randomised Controlled Trial Using Pulsed Current Stimulation Versus Melatonin

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DEVICE	transcranial pulsed current stimulation	A form of transcranial electrical stimulation that delivers unidirectional monophasic rectangular pulses of current.
DRUG	Melatonin	Melatonin

Timeline

• Start date: 2023-07-24
• Primary completion: 2024-03-31
• Completion: 2024-09-30
• First posted: 2024-02-01
• Last updated: 2024-02-01

Locations

1 site across 1 country: Singapore