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Effects of melatonin treatment, light therapy, and sleep improvement in children with Delayed Sleep Phase Syndrome


- candidate number15041
- NTR NumberNTR4045
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jun-2013
- Secondary IDsNL38852.018.12 2012-000220-18
- Public TitleEffects of melatonin treatment, light therapy, and sleep improvement in children with Delayed Sleep Phase Syndrome
- Scientific TitleEffects of melatonin treatment, light therapy, and sleep improvement on psychosocial, cognitive, and behavioural outcomes in children with Delayed Sleep Phase Syndrome and their parents
- ACRONYM
- hypothesisThe general aim of the present study is to investigate, in a longitudinal-experimental design, the effects of melatonin treatment and light therapy in children on sleep, health, and various psychosocial, behavioural, and cognitive outcomes. A second aim is to investigate whether improvements in psychosocial, behavioural and cognitive outcomes can be attributed to improved sleep, or to melatonin or light therapy itself. Third, relationships between children’s sleep, functioning, and parenting will be examined.
- Healt Condition(s) or Problem(s) studiedDelayed Sleep Phase Syndrome (DSPS), Insomnia
- Inclusion criteria- The child is between 7 and 12 years old, and
- 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),
b. the symptoms are present for at least 4 nights a week, for at least 1 month during a regular school period, and
- 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, and
- 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.
- Exclusion criteria- 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 â-blockers within 4 weeks before enrolment
- total IQ <80.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate1-sep-2015
- Target number of participants192
- InterventionsThe study has an experimental design with 3 groups: “melatonin”, “placebo melatonin”, and “light therapy”. Children are randomly assigned to one of the groups. After a baseline period of one week, children receive melatonin treatment, placebo melatonin, or light therapy for four weeks. A follow-up takes place 12 weeks later.
- Primary outcomebehaviour problems and cognitive functioning
- Secondary outcomeDLMO, sleep onset time and chronic sleep reduction
- TimepointsAfter 4 weeks treatment and 12 weeks follow-up
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Annette Maanen, van
- CONTACT for SCIENTIFIC QUERIES Annette Maanen, van
- Sponsor/Initiator Research Institute of Child Development and Education, University of Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Pharma Nord
- PublicationsN/A
- Brief summaryThere is much evidence that quality and quantity of sleep is related to psychosocial and behavioural outcomes in children. Although there is a large amount of evidence indicating that sleep restriction leads to impaired functioning, much less evidence is available for the effects of sleep improvement. The current study aims to examine the psychosocial, behavioural, and cognitive effects of sleep improvement in children with insufficient sleep due to Delayed Sleep Phase Syndrome (DSPS). The general aim of the present study is to investigate, in a longitudinal-experimental design, the effects of melatonin treatment and light therapy in children on sleep, health, and various psychosocial, behavioural, and cognitive outcomes. A second aim is to investigate whether improvements in psychosocial, behavioural and cognitive outcomes can be attributed to improved sleep, or to melatonin or light therapy itself. Third, relationships between children’s sleep, functioning, and parenting will be examined.
- Main changes (audit trail)
- RECORD26-jun-2013 - 8-jul-2013


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