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Clinical Trials/NL-OMON39468
NL-OMON39468
Completed
Not Applicable

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 sites192 target enrollmentTBD
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Conditionsslaapstoornissen/circadiane ritmiekstoornissendelayed sleep phase syndromesleep onset insomnia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
slaapstoornissen/circadiane ritmiekstoornissen
Sponsor
niversiteit van Amsterdam
Enrollment
192
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversiteit van Amsterdam

Eligibility Criteria

Inclusion Criteria

  • •\- 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

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

Outcomes

Primary Outcomes

Not specified

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