MMT cream for sleep induction in children with special needs (Mothers Melatonin touch )
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Melatonin cream induces sleep in special children
研究概览
简要总结
Many children with autism, ADHD, or cerebral palsy struggle to fall asleep, which affects their mood, learning, and family well-being. Current sleep medicines like oral melatonin can be hard to swallow, have variable absorption, or cause fear of dependency. To solve this, we developed MMT Cream (Mother’s Melatonin Touch)—a gentle transdermal cream with 1 mg melatonin per gram, combined with soothing scents like lavender or vanilla. It is applied on the child’s chest, wrist, or feet during bedtime, allowing both calming touch and hormonal sleep support at the same time.This pilot study will include 15–20 children aged 3–10 years. For 2 weeks, we will observe their normal sleep (baseline), then give the cream daily for 4 weeks. Sleep onset time, total sleep, night awakenings, and parent satisfaction will be measured using actigraphy, sleep questionnaires, and diaries.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 3.00 Year(s) 至 10.00 Year(s)(—)
- 性别
- All
入选标准
- •children aged between 3 to 10 years admitted in our hospital with neurodevelopmental disorders.
排除标准
- •those not providing consent for participation in our study.
结局指标
主要结局
Melatonin cream induces sleep in special children
时间窗: baseline,4 week, 8 weeks
次要结局
未报告次要终点
研究者
Dr Akshai
Saveetha medical college hospital
