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


- candidate number24186
- NTR NumberNTR5930
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-apr-2016
- Secondary IDs16/046 METC UMC Utrecht
- Public TitleLong term effects on sleep quality and adverse effects related to (continued) melatonin use since early childhood.
- Scientific TitleLong term effects on sleep quality and adverse effects related to (continued) melatonin use since early childhood.
- ACRONYMMELDOS LT2
- hypothesis
- Healt Condition(s) or Problem(s) studiedMelatonin, Sleep quality
- Inclusion criteriaAll participants from the MELDOS trial (ISRCTN20033346)
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mei-2016
- planned closingdate1-jul-2016
- Target number of participants72
- InterventionsData 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.
- Primary outcomeCurrent melatonin therapy status ((dis)continuation of therapy, dose, compliance, drug holidays, rebound sleep disturbance after (temporary) cessation of therapy, reason(s) for cessation or resuming of therapy) and current sleep habits (PSQI and ISI score).
- Secondary outcomeSecondary outcomes are chronotype (MEQ score, MSFsc), caffeine consumption, smoking status, use of electronics before bedtime and pubertal development. Furthermore, possible side effects and adverse events will be evaluated.
- TimepointsN/A
- Trial web siteN/A
- status[default]
- CONTACT FOR PUBLIC QUERIES I.M. van Geijlswijk
- CONTACT for SCIENTIFIC QUERIES I.M. van Geijlswijk
- Sponsor/Initiator Faculty of Veterinary Medicine, Pharmacy Department, Utrecht University, Gelderse Vallei Hospital Ede
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryBackground
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.
- Main changes (audit trail)
- RECORD4-apr-2016 - 8-aug-2016


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