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

Not Applicable

Recruiting

• Conditions: Neurodevelopmental Disorders; Insomnia
• Interventions: Device: transcranial pulsed current stimulation; Drug: Melatonin

• Registration Number: NCT06236191
• Lead Sponsor: KK Women's and Children's Hospital

Brief 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.

Study Timeline

• Study Start: 2023-07-24
• Study First Submitted: 2023-07-31
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	transcranial pulsed current stimulation	Intervention group is transcranial pulse electrical stimulation
Comparator	Melatonin	comparator is Melatonin

Primary Outcome Measures

Name	Time	Method
Total sleep time (TST)	4 weeks	Improvement in TST; the higher the TST the better

Secondary Outcome Measures

Name	Time	Method
Sleep efficiency (SE)	4 weeks	Increase in sleep efficiency (%); the higher the sleep efficiency the better
wake after sleep onset (WASO)	4 weeks	Reduction in WASO; the lower the WASO the better
Sleep latency (SL)	4 weeks	Reduction in sleep latency (min); the lower the sleep latency the better
Total score in sleep questionnaire	4 weeks	Reduction in total score in sleep questionnaire; max score 130 minimum score 26; the lower the better

Trial Locations

Locations (1)

KKWCH; 🇸🇬 Singapore, Singapore