Delayed Sleep Phase Syndrome
Conditions
Interventions
Trade Name: Bio-Melatonin
Pharmaceutical Form: Tablet
CAS Number: 73-31-4
Other descriptive name: MELATONIN
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 2.85-3.1
Sponsors
University of Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The general aim of the present study is to investigate, in a longitudinal-experimental design, the effects of melatonin treatment and light therapy in children on sleep, health, and various psychosocial, behavioural, and cognitive outcomes. ;Secondary Objective: A second aim is to investigate whether improvements in psychosocial, behavioural and cognitive outcomes can be attributed to improved sleep, or to melatonin or light therapy itself. Third, relationships between children’s sleep, functioning, and parenting will be examined.;Primary end point(s): Significant improvements in sleep (shorter sleep onset latency, earlier sleep onset time, longer total sleep time) during treatment compared to baseline. ;Timepoint(s) of evaluation of this end point: Directly after the last participant finished his/her treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Significant improvements on variables measured with the questionnaires (attention problems, child behaviour, inhibitory control, mood, health, functioning at school, parental sleep, parenting stress, parenting) and cognitive tests during and directly after treatment compared to baseline, and significant earlier Dim Light Melatonin Onset directly after treatment compared to baseline.;Timepoint(s) of evaluation of this end point: Directly after the last participant finished his/her treatment. | — |
Countries
Netherlands
Contacts
Public ContactResearch Institute
University of Amsterdam
Outcome results
None listed