Melatonin treatment and sleep disorders among children and adolescents with neurodevelopmental disorders – Morpheus trial

The project

The prevalence of sleep disorders among children and adolescents with neurological and psychiatric disorders is high. As sleep plays an important role in health, behavior, cognitive function, learning and social relationships, focus on sleep and optimal treatment of possible sleep disorders have significant impact on the mental and physical well-being of patients and their relatives.
In recent years, the number of children and adolescents treated with melatonin has doubled, although melatonin is not approved for the treatment of sleep disorders among children and adolescents and there is lacking evidence regarding indication, dosage, adverse effects and long-term effects of treatment with melatonin. 

In addition, there is no validated Danish pediatric sleep questionnaire, which could be used both as a screening tool for sleep disorders and as a marker for efficacy of treatment. 

In this study increased knowledge about indication, dosage, pharmacodynamics, effect, adverse effects, and long-term effects of treatment with melatonin among children and adolescents will be obtained. 

Furthermore, a Danish pediatric sleep questionnaire will be developed and validated. This will make it possible to screen pediatric patient populations for the presence of sleep disorders, to ensure a more evidence-based and personalised treatment and to provide basis for the development of national guidelines on investigation and individualized treatment of sleep disorders in children and adolescents.

Time frame

October 2018 - October 2023

Funding

Dronning Louises Børnehospitals Forskingsfond, AP Møller Fonden, Ongoing application to funds.
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