Long term effects on sleep quality and adverse effects related to (continued) melatonin use since early childhood.

Background

Melatonin is widely used for pediatric DSPD, in order to adjust children’s sleep timing to society’s school schedule time standards. Short term melatonin therapy appears to be safe. However, data on the effectiveness and safety of long term melatonin therapy remain scarce. As a result, opinions vary on whether long term melatonin therapy should be implemented so widely in pediatrics. Clearly, more data regarding long term melatonin therapy in pediatrics are needed.

Aims

The primary aim of this study is to evaluate participants’ melatonin use and sleep quality. Secondary aims are 1) to assess chronotype and lifestyle factors (e.g. smoking, caffeine intake and use of electronic devices before bedtime) and 2) to investigate occurrence of adverse events and (other) reasons for melatonin cessation.



Methods

All children that completed the melatonin dose finding (Meldos) trial (ISRCTN20033346) (n=69) were eligible to participate in this study. Data collection occured by use of an online questionnaire consisting of validated items assessing subjective sleep quality (PSQI), insomnia severity (ISI) and chronotype (MEQ, MCTQ). Furthermore, the questionnaire evaluated melatonin use, pubertal development and the abovementioned lifestyle factors. Results were compared to data regarding the general Dutch population.

N/A

Data collection will occur through administration of an electronic, retrospective, self-administered questionnaire. Comprising seven parts, the questionnaire assesses demographics, melatonin therapy status, chronotype, sleep quality, pubertal development, smoking behavior, caffeine consumption and use of electronics before bedtime. In total, the questionnaire comprises 101 questions. Depending on their answers, participants come across 46-81 items which take approximately 10-20 minutes to complete.