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

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

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Neurodevelopmental Disorders
• Intervention / Treatment: Drug: Melatonin; Device: transcranial pulsed current stimulation

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhi Min Ng, MBBS, MRCPCH; Phone Number: +65-6394 8975; Email: ng.zhi.min@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • Recruiting
    • KKWCH
    • Contact: Zhi Min Ng, MBBS; Email: ng.zhi.min@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Intervention group is transcranial pulse electrical stimulation	Device: transcranial pulsed current stimulation; A form of transcranial electrical stimulation that delivers unidirectional monophasic rectangular pulses of current.
Active Comparator: Comparator; comparator is Melatonin	Drug: Melatonin; Melatonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total sleep time (TST)	Improvement in TST; the higher the TST the better	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Zhi Min Ng, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 2022/2216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sleep data including TST, SL, SE, WASO can be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No