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

niversity of Amsterdam0 个研究点开始时间: 2012年4月17日最近更新: 2013年4月1日

试验速览

暂无简介。

•- The child is between 7 and 12 years old.
•- The child has DSPS, which is indicated by:
•(a) a complaint of an inability to fall asleep at the desired clock time, an ability to awaken spontaneously at the desired time of awakening, or excessive sleepiness,
•(b) there is a phase delay of the major sleep episode in relation to the desired time for sleep,
•(c) the symptoms are present for at least 1 month,
•(d) when not required to maintain a strict schedule (e.g., vacation time), patients will exhibit all of the following: (1) have a habitual sleep period that is sound and of normal quality and duration, (2) awaken spontaneously, (3) maintain stable entrainment to a 24-hour sleep-wake pattern at a delayed phase,
•(e) sleep-wake logs must demonstrate evidence of a delay in the timing of the habitual sleep period.
•- Dim Light Melatonin Onset (DLMO) later than 20.00 h.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 192
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

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

发起方

niversity of Amsterdam