Improving Sleep of Children With Neurodevelopmental Disorders: A Prospective, Randomised Controlled Trial Using Pulsed Current Stimulation Versus Melatonin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total sleep time (TST)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor assessing sleep data will be blinded
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention
Intervention group is transcranial pulse electrical stimulation
干预措施: transcranial pulsed current stimulation (Device)
Comparator
comparator is Melatonin
干预措施: Melatonin (Drug)
结局指标
主要结局
Total sleep time (TST)
时间窗: 4 weeks
Improvement in TST; the higher the TST the better
次要结局
- Sleep efficiency (SE)(4 weeks)
- wake after sleep onset (WASO)(4 weeks)
- Sleep latency (SL)(4 weeks)
- Total score in sleep questionnaire(4 weeks)
研究者
Ng Zhi Min
Principal Investigator
KK Women's and Children's Hospital