With this study we aim to investigate the emotional development, behavior, social behavior, variation in personality traits and intellectual functioning in a group of children who are diagnosed with narcolepsy with of without cataplexie, according…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Given the exploratory nature of the study, there are several primary study
parameters. Regarding the personality there is particular interest in the
dimensions: 'extraversion' and 'emotional stability'. These are obtained from
the Hierarchical personality questionnaire for children (HIPIC) and the
Dimensional Personality Symptom Item Pool (DiPSI) and serve as the primary
study parameter for personality traits. Social behavior is measured by the
subscale 'autistic behaviors' obtained from the Social Emotional Questionnaire
(SEV). The overall IQ score obtained from the Wechsler Intelligence Scale
(WISC-III-NL) is chosen as the primary parameter for intellectual functioning.
Secondary outcome
Secondary outcome measures include 'internalizing' from the Child Behavior
Checklist (CBCL) and the total score of the Child Depression Inventory (CDI).
Background summary
Narcolepsy is a chronic, neurological sleep disorder characterized by excessive
daytime sleepiness (often manifested in uncontrollable sleep attacks),
cataplexy, sleep paralysis, hypnagogic hallucinations and disturbed nocturnal
sleep. In the late 90's it was clear that narcolepsy is caused by a deficiency
or absence of a neuropeptide called hypocretin (or orexin), which is produced
by localized neurons in the lateral hypothalamus. Although it was previously
believed that narcolepsy in childhood was rare, it is now clear that the
complaints are often manifest in childhood. It is generally assumed that
children with narcolepsy have a different behavioral and psychological profile
compared to children without narcolepsy, however nuanced and longitudinal
research on various aspects of the behavioral and psychological functioning and
its development is lacking to date.
Study objective
With this study we aim to investigate the emotional development, behavior,
social behavior, variation in personality traits and intellectual functioning
in a group of children who are diagnosed with narcolepsy with of without
cataplexie, according to the ICSD-2 criteria. The results will be compared with
the results of a group of children with juvenile idiopathic arthritis and a
healthy control group. By comparing the results of the narcolepsy group with
the results of the juvenile ideopathic artritis group, we gain information
about the specificity of the results. Are the results unique for narcolepsy, of
do they appear to be related to the overall burden of chronic diseases? The
variables will be monitored in time and the effect of the narcolepsy treatment
on these variables is evaluated.
Study design
The study is exploratory. The design is longitudinal with a cross sectional
analysis at T0. Both children who have a diagnoses of narcolepsy as children
who receive a diagnoses of narcolepsy during the course of the study, will be
followed. In total there will be 3-4 (depending on the time of diagnosis)
measuring moments, in we use questionnaires as instruments. The children who
receive a diagnoses of narcolepsy during the course (inclusion time 2 years),
will also be tested on intelligence and some additional concentration tasks
before the treatment of narcolepsy has started. These test will be repeated
after one year.
Study burden and risks
The study requires effort of parent (s) / guardian (s) and the child itself.
Parent (s) / guardian (s) and children receive a set of questionaires 3 to 4
times in a time span of 2 years. They are requested to complete the set of
questionnaires and return these. The time investment per set of questionnaire
for parents is approximately 110 minutes and for the child about 50 minutes.
Children with a 'new diagnoses' of narcolepsy will be administered an
intelligence test and some additional concentration tasks on two different
times. This will take approximately 90 minutes each time. If desired, the
results of this intelligence task can be shared whit the child and the paren
(s)/ guardian (s).
Sterkselseweg 65
Heeze 5591 VE
NL
Sterkselseweg 65
Heeze 5591 VE
NL
Listed location countries
Age
Inclusion criteria
Narcolepsy:
- Children with the diagnoses of narcolepsy according to the ICSD-2 criteria (both with and without cataplexy);- Due to age restrictions of the various instruments, children from 7 to 16 years old will be included in this study. For children who are diagnosed with narcolepsy during the course of the study and will participate as 'new diagnosis', an upper limit of 15 years has to be maintained. This is related to the age restriction of the WISC III NL;- Under treatment at one of the participating centers (ie Kempenhaeghe, UZ Gent, MC Haaglanden and LUMC);Juvenile idiopathic arthritis:;- Children with a diagnosis of juvenile idiopathic arthritis according to ILAR classification
- Children between the ages of 7 to 16 years
- At least one year under the supervision of a specialist
- Minimal treatment with NSAIDs and MTX;Healthy controls:;- Children between the ages of 7 to 16 years
- No medical diagnosis / treatment
Exclusion criteria
For both clinical groups and healthy controls:;- - Intellectual disability of the child (IQ <70)
- Intellectual disability of either parent (s) / guardian (s) (IQ <70)
- Problems with command of the Dutch language by the child
- Problems with command of the Dutch language by both parent (s) / guardian (s);Additional for healthy controls:
- A medical diagnosis requiring active treatment
Design
Recruitment
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL44822.058.13 |