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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
slaapstoornissen/circadiane ritmiekstoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary endpoints are DLMO, sleep onset time, chronic sleep reduction,
behaviour problems, and cognitive functioning.
Secondary outcome
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.
Background summary
There 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).
Study objective
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.
Study design
The study uses a longitudinal-experimental design (double blind placebo
controlled).
Intervention
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, children receive melatonin
treatment, placebo melatonin, or light therapy. After four weeks, children in
the placebo condition receive melatonin treatment. Children in the other two
groups continue their treatment.
Study burden and risks
Children and parents have to complete questionnaires at three measurement
occasions over a period of 17 weeks. In addition, parents have to complete
daily sleep diaries for 7 weeks in total, and children have to wear actometers
during these periods. Also, at the three measurement occasions children have to
complete cognitive tasks on a laptop and at two measurement occasions saliva
samples are taken hourly from 19:00-23:00 h to determine DLMO. Parents and
children have three site visits in 17 weeks. The risks associated with
participation in the study can be considered negligible.
Nieuwe Prinsengracht 130
Amsterdam 1018 VZ
NL
Nieuwe Prinsengracht 130
Amsterdam 1018 VZ
NL
Listed location countries
Age
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 *-blockers within 4 weeks before enrolment
- total IQ <80
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000220-18-NL |
| CCMO | NL38852.018.12 |
| OMON | NL-OMON28494 |