Clinical trial NCT06236191: Improving Sleep of Children With Neurodevelopmental Disorders: Pulsed Current Stimulation Versus Melatonin
Official title: Improving Sleep of Children With Neurodevelopmental Disorders: A Prospective, Randomised Controlled Trial Using Pulsed Current Stimulation Versus Melatonin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Neurodevelopmental Disorders
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover trial using Balaam's design
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Total sleep time (TST)
timeFrame: 4 weeks
Secondary outcomes:
measure: Sleep latency (SL)
timeFrame: 4 weeks
measure: Sleep efficiency (SE)
timeFrame: 4 weeks
measure: wake after sleep onset (WASO)
timeFrame: 4 weeks
measure: Total score in sleep questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KKWCH
Study officials:
affiliation: KK Women's and Children's Hospital
name: Zhi Min Ng
role: PRINCIPAL_INVESTIGATOR
References: