跳至主要内容
临床试验/CTRI/2025/11/097672
CTRI/2025/11/097672尚未招募3 期

MMT cream for sleep induction in children with special needs (Mothers Melatonin touch )

Saveetha medical college hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月19日最近更新:

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

发起方
Saveetha medical college hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Akshai

Saveetha medical college hospital

研究点 (1)

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