Melatonin for children with idiopathic chronic sleep onset insomnia, with or without attention deficit hyperkinesia disorder - A dosefinding trial.A randomised placebo-controlled double-blind parallel group trial.
Suspended
- Conditions
- Children with chronic sleep onset insomnia without or with ADHD.
- Registration Number
- NL-OMON19948
- Lead Sponsor
- I.M. van Geijlswijk, ziekenhuisapothekerZiekenhuisapotheek Gelderse ValleiWilly Brandtlaan 106716 RP Ede0318-435693geijlswijki@zgv.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
1. At inclusion physical examination, medial history and inclusion/exclusion assessments will be performed. The results of a hypnogram, performed within the past two months, showing a normal sleep architecture has to be known at inclusion;
2. The children and their parents have to be motivated to comply the study protocol.
Exclusion Criteria
1. Child-psychiatric or family problems who can explain the sleep onset insomnia;
2. Disturbed sleeparchitecture (hypnogram);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Actigraphic sleep onset and offset and melatonin onset (defined as the time at which 4 pg/ml melatonin in saliva is reached), diary lights-off time, sleep latency (latency between lights-off and sleep onset), sleep onset, sleep duration, sleep-offset and wake up time, behaviour and health status.
- Secondary Outcome Measures
Name Time Method Furthermore possible side effects and adverse events will be evaluated.