Effects of melatonin treatment, light therapy, and sleep improvement in children with sleep onset problems

• Conditions: Delayed Sleep Phase Syndrome; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2012-000220-18-NL
• Lead Sponsor: niversity of Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-17
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- The child is between 7 and 12 years old.
- The child has DSPS, which is indicated by:
(a) a complaint of an inability to fall asleep at the desired clock time, an ability to awaken spontaneously at the desired time of awakening, or excessive sleepiness,
(b) there is a phase delay of the major sleep episode in relation to the desired time for sleep,
(c) the symptoms are present for at least 1 month,
(d) when not required to maintain a strict schedule (e.g., vacation time), patients will exhibit all of the following: (1) have a habitual sleep period that is sound and of normal quality and duration, (2) awaken spontaneously, (3) maintain stable entrainment to a 24-hour sleep-wake pattern at a delayed phase,
(e) sleep-wake logs must demonstrate evidence of a delay in the timing of the habitual sleep period.
- Dim Light Melatonin Onset (DLMO) later than 20.00 h.

Are the trial subjects under 18? yes
Number of subjects for this age range: 192
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-pervasive developmental disorder
-chronic pain
-known disturbed hepatic or renal function
-Roter or Dubin-Johnson syndrome
-epilepsy
-use of stimulants, neuroleptics, benzodiazepines, clonidine, antidepressants, hypnotics, or ß-blockers within 4 weeks before enrolment
-total IQ <80

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified