The aim is to establish a correlation between sleep time and sleep efficiency, measured by actigraphy and daytime functioning (irritability, drowsiness and physical activity) of adults with a moderate intellectial disability.
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of sleep: sleep time and sleep efficiency
Daytime functioning: irritability, physical activity and daytime sleepiness.
Secondary outcome
There are many factors that might influence sleep and behaviour in this
population, and therefore have to be taken into account. They concern
demographic information (gender, age, level of ID), co-morbidity (dementia,
epilepsy, spasticity, obesitas), use of medication with sedative effects
(anti-epileptics, benzodiazepines, antidepressants, antipsychotics and
melatonin) and mobility.
Background summary
In the general population many studies are conducted on sleep and sleep
problems. There is a clear definition for insomnia, defined by the Dutch
general practitioners as: sleep deprivation and poor sleep, such as frequent
awakenings or restless dreams, accompanied by daytime functioning complaints,
like fatigue, drowsiness, irritability, impaired concentration and performance.
Less is known about the consequences of a bad sleep quality in persons with ID.
A large part of this population is not able to mention sleep problems reliably
and risk factors for sleep disorders are prevalent in this group. Therefore
objective measurement of sleep and daytime functioning is highly desirable
Study objective
The aim is to establish a correlation between sleep time and sleep efficiency,
measured by actigraphy and daytime functioning (irritability, drowsiness and
physical activity) of adults with a moderate intellectial disability.
Study design
All clients living in the participating institutions with a moderate
intellectual disability will be listed. Sixty clients will be selected at
random from this list using a random number generator (http://www.random.org).
Informed consent will be acquired from all participants and from their legal
representatives.
1. After informed consent is provided, all participants are instructed to wear
the Vivago® accelerometer 7 days and nights continuously.
2. Caregivers are asked to fill in the ESS on the last day that the watch will
be worn.
3. Caregivers are asked to fill in the ABC subscale I, on the last daythat the
watch will be worn.
Study burden and risks
The client will wear a accelerometer on his/her wrist, which he/she has to wear
day and night during 7 days. No further actions or behaviour will be asked from
the client. He/she can undertake all his/her normal activities.
After 7 days a caregiver will be asked to fill in 2 questionnaires.
The vivagowatch has the size of a watch. Therefore we expect no or minimal load
for the client. In case the client does experience a negative load, the
vivagowatch will be taken off and the client will be excluded from the
research.
Ter hoogte van Dr. Molewaterplein 50
Rotterdam 3015 GJ
NL
Ter hoogte van Dr. Molewaterplein 50
Rotterdam 3015 GJ
NL
Listed location countries
Age
Inclusion criteria
18-50 years of age
receiving care from participating care-organisation
a moderate intellectual disability
Exclusion criteria
Participants who refuse to wear the actigraph, or are known by their professional caregivers to easily lose or break things will be excluded from the study.
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 | NL47672.078.14 |