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临床试验/ISRCTN92655217
ISRCTN92655217已完成未知

Snuggledown - The use of sensory weighted blankets in children with autistic spectrum disorders and poor sleep: a randomised crossover study

Guy's and St.Thomas' NHS Foundation Trust (UK)0 个研究点目标入组 100 人开始时间: 2011年8月10日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Children aged 5 to 15 years and 10 months with a diagnosis of an autistic spectrum disorders (ASD), diagnosed by a community paediatrician, paediatric neurologist or paediatric neurodisability consultant
  • 2. No plans to commence new medication known to influence behaviour or sleep
  • 3. Diagnosis of impaired sleep as defined by a) not falling asleep within one hour of 'lights off' or 'snuggling down to sleep' at age-appropriate times and/or b) less than 7 hours of continuous sleep in 3 out of 5 nights
  • 4. A total score of <4 on questions 18 to 20 on the Children's Sleep Habits Questionnaire indicating the likely absence of sleep apnoea
  • 5. Parental English language sufficient to read and complete questionnaires and sleep diaries
  • 6. Ability to start each night's sleep in own bed
  • 7. Male and female participants

排除标准

  • 1. Children who are using a weighted blanket
  • 2. Children whose parents are unlikely to be able to use the actigraph or complete sleep diaries or both
  • 3. Children where there may be a problem of major non-concordance with blanket or actigraph
  • 4. Currently participating in a conflicting clinical study
  • 5. Epilepsy (uncontrolled or medication changes)
  • 6. Cerebral palsy

研究者

发起方
Guy's and St.Thomas' NHS Foundation Trust (UK)

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