E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Delayed Sleep Phase Syndrome |
Verlaat slaapfase syndroom |
|
E.1.1.1 | Medical condition in easily understood language |
Sleep onset problems |
Inslaapproblemen |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Het algemene doel van dit onderzoek is om in een longitudinaal-experimenteel design, de effecten van melatoninebehandeling en lichttherapie op slaap, gezondheid en verschillende psychosociale, gedrags- en cognitieve uitkomstmaten bij kinderen te onderzoeken. |
|
E.2.2 | Secondary objectives of the trial |
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. |
Een tweede doel is om te onderzoeken of verbeteringen in psychosociale, gedrags- en cognitieve uitkomsten toegeschreven kunnen worden aan verbeterde slaap, of aan melatonine of lichttherapie zelf. Een derde doel is om de relaties tussen slaap en functioneren van kinderen en opvoeding te onderzoeken. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
- Het kind is tussen 7 en 12 jaar oud. - Het kind heeft DSPS, wat blijkt uit: (a) Een klacht over een onvermogen in slaap te vallen op de gewenste tijd, een onvermogen spontaan te ontwaken op de gewenste tijd, of excessieve slaperigheid (b) Er is een verschuiving van de voornaamste slaapepisode in relatie tot de gewenste slaaptijd (c) De symptomen zijn minstens 1 maand aanwezig (d) Wanneer het niet noodzakelijk is een strikt schema aan te houden (bijv. in vakantietijd), hebben patiënten het volgende: (1) een gebruikelijke slaapperiode van normale kwaliteit en duur, (2) spontaan ontwaken, (3) behoud van een stabiel 24-uurs-slaapwaakpatroon in een verlate fase (e) Slaapdagboekjes tonen een verlate timing van de gebruikelijke slaapperiode. - Dim Light Melatonin Onset (DLMO) later dan 20.00 uur. |
|
E.4 | Principal 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 β-blockers within 4 weeks before enrolment - total IQ <80 |
- pervasieve ontwikkelingsstoornis - chronische pijn - verstoorde lever- of nierfunctie - Roter of Dubin-Johnson syndroom - Epilepsie - Gebruik van opwekkingsmiddelen, neuroleptica, benzodiazepines, clonidine, antidepressiva, hypnotica of β-blokkers binnen 4 weken voor de inclusie - Totaal IQ<80 |
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E.5 End points |
E.5.1 | 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. |
Significante verbeteringen in slaap (kortere slaaplatentie, eerdere inslaaptijd, langere slaapduur) tijdens de behandeling in vergelijking met baseline. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Directly after the last participant finished his/her treatment. |
Direct na het einde van de laatste behandeling van de laatste patiënt. |
|
E.5.2 | 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. |
Significante verbeteringen op variabelen gemeten met de vragenlijsten (aandachtsproblemen, gedrag van het kind, inhibitiecontrole, stemming, gezondheid, functioneren op school, slaap van de ouders, opvoedingsstress, opvoeding) en cognitieve tests gedurende en direct na de behandeling vergeleken met baseline, en significant vervroegde Dim Light Melatonin Onset direct na behandeling vergeleken met baseline. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Directly after the last participant finished his/her treatment. |
Direct na het einde van de laatste behandeling van de laatste patiënt. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Secundary and indirect effects |
Secundaire en indirecte effecten |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
lichttherapie |
light therapy |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |