Effects of melatonin treatment, light therapy, and sleep improvement on psychosocial, cognitive, and behavioural outcomes in children with Delayed Sleep Phase Syndrome and their parents - Melatonin treatment, light therapy, and sleep improvement in children

niversiteit van Amsterdam0 个研究点目标入组 192 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•- The child is between 7 and 12 years old,
•- The child has chronic sleep onset problems, which is indicated by:
•a. complaint of inability to fall asleep at the desired clock time (Sleep onset later than 20:45 h in children aged 7 years and for older children 15 minutes later per year until and including age 12, and a latency between lights-off time and sleep onset (sleep onset latency) of more than 30 minutes),
•the symptoms are present for at least 4 nights a week, for at least 1 month during a regular
•school period,
•- Dim Light Melatonin Onset (DLMO, the clock time at which the endogenous melatonin secretion reaches the threshold of 4 pg/ml) later than 19:45 h in children aged 7 years and for older children 15 minutes later per year until and including age 12,
•- the sleep problems result in problems with daytime functioning . Children should have the following symptoms:
•a) sleepiness/tiredness during the day
•and at least one of the following:
•b) external behaviour problems
•c) internal behaviour problems
•d) problems with functioning at school.

•- pervasive developmental disorder
•- chronic pain
•- known disturbed hepatic or renal function
•- Roter or Dubin-Johnson syndrome
•- epilepsy
•- use of stimulants, neuroleptics, benzodiazepines, clonidine, antidepressants, hypnotics, or *-blockers within 4 weeks before enrolment
•- total IQ <80

发起方

niversiteit van Amsterdam