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

2022/2216

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

2023-07-24

2024-03-31

2024-09-30

Recruiting

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': "Crossover trial using Balaam's design", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Outcome assessor assessing sleep data will be blinded', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-02-01