slaapstoornissen/circadiane ritmiekstoornissen delayed sleep phase syndrome sleep onset insomnia
Conditions
Interventions
The 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, c
Sponsors
Universiteit van Amsterdam
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
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
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 *-blockers within 4 weeks before enrolment - total IQ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary endpoints are DLMO, sleep onset time, chronic sleep reduction, behaviour problems, and cognitive functioning. | — |
Secondary
| Measure | Time frame |
|---|---|
| Significant improvements on other variables measured with the questionnaires (attention problems, inhibitory control, mood, health, functioning at school, parental sleep, parenting stress, parenting) during and directly after treatment compared to baseline. | — |
Countries
Netherlands
Outcome results
None listed