Sleep problems in children with Angelman syndrome: the effect of a behavioral treatment.
- Conditions
- Angelman syndrome10029299
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 32
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.
- 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcomes are the actual hours of sleep during the night and sleep<br /><br>behaviour of the children, as reported in the sleep diary, measured with the<br /><br>actigraphy and video registration and expressed by the Composite Sleep Index<br /><br>(CSI), calculated from the sleep questionnaire.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are sleep hygiene, melatonin levels, daytime functioning and<br /><br>Quality of Life of the children, as well as the actual hours of sleep of the<br /><br>parents, parental stress and their Quality of Life. </p><br>