MELatonin for children with idiopathic chronic sleep onset insomnia, with or without attention deficit hyperkinesia disorder - a DOSe finding trial: a randomised placebo-controlled double-blind parallel group trial

Completed

Conditions: Insomnia, Attention Deficit Hyperactivity Disorder (ADHD), sleep disorders
Mental and Behavioural Disorders
Behavioural Disorders

Registration Number: ISRCTN20033346

Lead Sponsor: Hospital Pharmacy of the Valley of Gelderland (Ziekenhuisapotheek Gelderse Vallei) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

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 sleep architecture (hypnogram)
3. Use of Monoamine Oxidase (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 (Intelligence Quotient [IQ] less than 80)
11. Any prior use of melatonin
12. Use of hypnotics, antidepressants or neuroleptics
13. Chronic pain
14. Severe neurological or psychiatric disorder

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Actigraphic sleep onset and offset and melatonin onset (defined as the time at which 4 pg/ml melatonin in saliva is reached) <br>2. Diary lights-off time<br>3. Sleep latency (latency between lights-off and sleep onset)<br>4. Sleep onset<br>5. Sleep duration<br>6. Sleep-offset and wake up time<br>7. Behaviour<br>8. Health status<br><br>Actigraphy data (for measurement of primary outcomes 1, 3, 4, 5 and 6) are collected during five days of week one, and five days of week two. Saliva collection (for the measurement of primary outcome 1) is done on day seven of week one and day seven of week two, for measurement of melatonin onset. The diary is recorded during all 14 days of the trial duration (for measurements of primary outcomes 2, 7, 8, and secondary outcome).<br><br>At this moment an interim analysis of the actigraphy results of week one (no medication) versus week two (with double blind placebo controlled medication) is ongoing, after 75 patients enrolled.

Secondary Outcome Measures