Effects of melatonin treatment, light therapy, and sleep improvement on psychosocial, cognitive, and behavioural outcomes in children with Delayed Sleep Phase Syndrome and their parents - Melatonin treatment, light therapy, and sleep improvement in children

niversity of Amsterdam0 sitesApril 17, 2012

Overview

No summary available.

Registry

who.int

Start Date

April 17, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Amsterdam

•\- 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

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