ong term effects on sleep quality and adverse effects related to (continued) melatonin use since early childhood.
- Conditions
- CSOI, melatonin, sleep quality
- Registration Number
- NL-OMON25842
- Lead Sponsor
- Faculty of Veterinary Medicine, Pharmacy Department, Utrecht University. In samenwerking met Gelderse Vallei Hospital Ede.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
All participants from the MELDOS trial (ISRCTN20033346)
Exclusion Criteria
N/A
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current 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).<br>
- Secondary Outcome Measures
Name Time Method Secondary 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.