The first objective of this study is to investigate the feasibility of performing home sleep EEG registrations in older people with intellectual disability. The second objective of this study is the determine which sensitivity setting of the Sleep…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of performing home sleep EEG registrations, together with a
Actiwatch measurement, in older people with intellectual disability.
Secondary outcome
Sensitivity, specificity and accuracy of two different types of Actiwatch
compared to sleep registratrion (for the low, medium, high and auto sensitivity
setting)
Differences between the sleep parameters Total Sleep Time, Sleep Efficiency,
Sleep Onset Latency, Wake After Sleep Onset (for the low, medium, high and auto
sensitivity setting)
Background summary
In the *Healthy aging with an intellectual disability study* (GOUD, METC
2008-234, NL 23941.078.08) the Actiwatch (Cambridge Neurotechnology Ltd,
Cambridge, United Kingdom) was used to investigate the rest - activity pattern.
This instrument is increasingly used in sleep research. The Actiwatch is a
small watch-like device which contains an accelometer, and is worn on the
wrist. It is non-invasive and can be used in the home environment. To register
sleep, the Actiwatch Sleep Analysis software uses an algorithm that looks at
each data point and calculates a total score, based on the activity counts from
each epoch and those surrounding it. The software provides four sensitivity
settings to analyze the data files: low sensitivity= 80 counts per epoch,
medium sensitivity=40 counts per epoch, high sensitivity=20 counts per epoch
and auto sensitivity=variable counts per epoch (the auto sensitivity setting
approximates the medium sensitivity setting). At the low sensitivity setting
(80 counts per epoch) more movement is necessary to score an epoch as awake,
than at the high sensitivity setting (20 counts per epoch). For example when
the sensitivity setting is set on medium, an epoch is scored as *asleep* when
the total activity score is <40 counts, and awake when the total activity score
exceeds 40 counts per epoch. To gain first information on the applicability and
outcomes of the Actiwatch in older people with intellectual disability, data
collected in the first year of GOUD were analyzed for the low and high
sensitivity setting. The first results show that the chosen sensitivity setting
has major influence on the values of different sleep parameters. In order to
make the right choice for sensitivity setting we want to validate the Actiwatch
with sleepregistration (golden standard) for older people with intellectual
disability. The feasibility of EEG-investigation in older people with
intellectual disability is investigated.
Study objective
The first objective of this study is to investigate the feasibility of
performing home sleep EEG registrations in older people with intellectual
disability. The second objective of this study is the determine which
sensitivity setting of the Sleep Analysis software gives
most valid results, in favor of the data analysis of the healthy aging (GOUD)
study.
Study design
Pilot study with a cross-sectional design
Study burden and risks
Participants will be measured for 48 hours with two types of Actiwatch (on the
wrist) and with sleepregistration (electrodes on head and face). The
measurement takes place in the home environment of the participant, so there is
no need for an overnight sleep in a sleep laboratory.
Participants have to be able to understand the measurements and give informed
consent themselves.
Burden can occur in terms of experiencing discomfort of the sleepregistration
electrodes and the data recorder. There is a small risk of skin irritation
caused by the Actiwatch or skin electrodes.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- at least 50 years of age
- intellectual disability
- competent to provide informed consent
- 5 participants with a known sleep problem
- 5 participatns without a sleep problem
Exclusion criteria
- active epilepsy
- behaviour problems that negatively influence the measurement
- not able to give informed consent themselves
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 | NL37485.078.11 |