Children with chronic sleep onset insomnia without or with ADHD.
Conditions
Interventions
The study lasts at 2 weeks. One baseline week, followed by 1 treatment week with melatonin 0,1 mg (commercially available OTC product), 0,05 mg/kg, 0,1 mg/kg, 0,15 mg/kg or placebo treatment.
Sponsors
I.M. van Geijlswijk, ziekenhuisapotheker
Ziekenhuisapotheek Gelderse Vallei
Willy Brandtlaan 10
6716 RP Ede
0318-435693
geijlswijki@zgv.nl
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Child-psychiatric or family problems who can explain the sleep onset insomnia; 2. Disturbed sleeparchitecture (hypnogram); 3. Use of MAO inhibitors; 4. Children with known disturbed hepatic or renal function; 5. Patients with the Roter syndrome; 6. Patients with the Dubin-Johnson syndrome; 7. Factors or diseases which can, according to the investigator, inhibit participation to the study; 8. Medical, environmental, psychiatric or other factors, which can cause sleep onset insomnia during the trial; 9. Participation in a study on the efficacy of drugs in the month preceding the inclusion; 10. Mental retardation (IQ<80); 11. Any prior use of melatonin; 12. Use of hypnotics, antidepressants or neuroleptics; 13. Chronic pain; 14. Severe neurological or psychiatric disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Furthermore possible side effects and adverse events will be evaluated. | — |
Contacts
Public ContactI.M. Geijlswijk, van
University Medical Center Utrecht (UMCU), Pharmacy of Faculty Animal Medicine
Outcome results
None listed