Angelman syndrome
Conditions
Interventions
Behavioural treatment by a behavioural therapist during 6 weeks, including a
house call in the first and third week and weekly contact by phone or video
call, followed by booster sessions by phone o
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: The child is between 2-17;11 years old, has genetically proven Angelan syndrome and has present sleep problems, defined as: 1. Two hours less sleep than normal for the age (defined as minimal of 12 hours for children of 2-4 year, 10 hours of 4-12 years and 8 hours of 12-18 years and/or 2. Sleeping less than 7 hours a night and/or 3. Composite Sleep Index >4 (based on the sleep questionnaire) and/or 4. Sleeping in another location than his/ her own bed, needing more than normal rituals to fall asleep (bottle in bed, holding and/or rocking by parents, persistent presence parent in the room or in bed and/or other rituals) - Somatic causes of sleep problems should be stable and optimally treated - No change in symptoms or medication during last 3 months (including anti-epileptic drugs, melatonin, pipamperone or other psychoactive drugs) - The children live at home with their parent(s) or caretaker(s). - Parents/caretakers have sufficient oral and written command of the Dutch language.
Exclusion criteria
Exclusion criteria: - younger than 2 or older than 18 years - angelman syndrome not genetically proven - No present sleep problems as defined in the inclusion criteria - New or unstable somatic causes for sleep problems. - Change in symptoms or medication during last 3 months (including anti-epileptic drugs, melatonin, pipamperone or other psychoactive drugs) - The children do not live at home with their parent(s) or caretaker(s). - Parents/caretakers do not have sufficient oral and written command of the Dutch language. - Tonic clonic seizures during the night observed by the parents and/or video registration (absences and other types of epilepsy are accepted since they are less interfering with sleep) - Baseline assessment did not succeed - High daytime melatonin levels (>50 pg/mL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes are the actual hours of sleep during the night and sleep behaviour of the children, as reported in the sleep diary, measured with the actigraphy and video registration and expressed by the Composite Sleep Index (CSI), calculated from the sleep questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are sleep hygiene, melatonin levels, daytime functioning and Quality of Life of the children, as well as the actual hours of sleep of the parents, parental stress and their Quality of Life. | — |
Countries
Netherlands
Outcome results
None listed