Primary Objective:To evaluate the effect and sustainability over time of behavioural treatment for sleep problems in children with AS on the actual hours of sleep and sleep behaviour of the children.Secondary Objectives:To evaluate the effect and…
ID
Source
Brief title
Acroniem: SLAAP
Condition
- Neurological disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Children with Angelman syndrome (AS) frequently have severe sleep problems.
These problems tend to be chronic and have a tremendous impact on the child,
the parents and the family life. Sleep problems are partly due to biological
factors and partly to behavioural factors. This study aims to evaluate the
effect of a behavioural treatment for sleep problems in children with AS.
Study objective
Primary Objective:
To evaluate the effect and sustainability over time of behavioural treatment
for sleep problems in children with AS on the actual hours of sleep and sleep
behaviour of the children.
Secondary Objectives:
To evaluate the effect and sustainability over time of behavioural treatment
for sleep problems in children with AS on sleep hygiene, melatonin levels,
Quality of Life and daytime functioning of the children and on parental Quality
of Life, actual hours of sleep and experienced stress.
Study design
Study design:
The study is a randomized controlled single blinded trial. Parents of children
with AS between 2 and 18 years are asked to fill in a combined sleep and
epilepsy diary, two sleep questionnaires, Quality of Life questionnaires about
themselves and their child, a questionnaire about experienced parental stress
and a questionnaire about the daytime functioning of their child. Saliva is
collected to measure melatonin levels. Parents are requested to let their child
wear an actigraph and be videorecorded during sleep for 7 nights.
The children with sleep problems at baseline assessment, as defined in section
4.2, will be randomized to a behavioural treatment for 6 weeks with a booster
session after 8 and 10 weeks from start (intervention group) or to a waiting
list for 6 months (control group). The control group will be used to rule out
spontaneous improvement over time. Randomized children will be stratified for
age. The effects will be evaluated single blinded at the end of the treatment
(t=12 weeks) and at 6 months from baseline.
Intervention
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 or video call after 8 and 10 weeks
from start treatment.
Study burden and risks
Participation will require time and effort of the parents by registration of
sleep and epilepsy of their children in a diary, filling in questionnaires and
follow an extensive treatment program. Saliva will be collected with a cotton
wool to chew on briefly or sweeped through their oral cavitiy by one of their
parents. The study will contain no extra visits to the hospital; the contact
will consist of two house calls and weekly phone or video calls during the
treatment program. There are no risks associated with participation. Potential
benefit is an improvement of sleep and daytime functioning of the child and
parents.
Wytemaweg 80 Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80 Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54868.078.15 |