The purpose of this study is to develop a sleep self-report instrument for people with a mild intellectual disability (SSR-ID) and to assess construct validity of the SSR-ID by showing its association with sleep parameters measured by actigraphy.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
slaappatroon
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Participants wear the actiwatch for seven consecutive days. In this period,
every morning the participant fills in the SSR-ID. At the end of the week, the
Actiwatch and the answers of the SSR-ID will be collected by the researcher and
the participant will be asked to evaluate their experience with the SSR-ID, by
answering the questions on the last pages included to the SSR-ID.
Then, data from the Actiwatch will be extracted using the Sleep Analysis
Software (see above). For the questionnaire, a sumscore of each item is derived
and a mean or median is calculated for respectively normal and non-normal
distributions. These scores eventually are correlated to the sumscores of the
actiwatch parameters
Actiwatch:
• Time in bed (TIB); total time the participants spend in bed.
• Sleep onset latency (SOL); the interval between bedtime and sleep start.
• Total sleep time (TST)
• The time awake between sleep start en sleep end (WASO)
• The percentage of time asleep during the total time in bed (sleep efficiency,
SE)
• Interval between sleep and get-up time (get-up time latency, GTL).
Sleep Self Report Questionnairre:
The development of the questions will be part of this research project. The
answers to the final questions can be correlated against parameters of the
actiwatch. Each item on the questionnaire will be answered for 7 times (7
consequetive days). We will use a weigthed mean of each item in our analysis.
For details, see the questionnaire in the protocol's attachment.
Secondary outcome
inapplicable
Background summary
Sleep problems are common in people with intellectual disabilities (ID) and
could lead to serious physical, mental health or behavioral problems. Early
recognition and prevention or treatment of sleep problems is necessary in
prevention of secondary health problems and behavioral issues. To assess sleep
in people with mild ID, nowadays caregivers should use methods, like
polysomnography and actigrapy, that are not always well tolerated by this group
and are often expensive and time-inefficient. It would be desirable if sleep
assessment can take place by a more easy and feasible instrument like a self-
report questionnaire. A sleep- self report questionnaire developed and adapted
to cognitive functioning and experience of people with mild ID, might be a
helpful tool in the communication between caregiver and patient. For there are
no sleep-self-report questionnaires for people with mild ID, we will develop
and validate the sleep self- report questionnaire for people with mild ID
(SSR-ID).
Study objective
The purpose of this study is to develop a sleep self-report instrument for
people with a mild intellectual disability (SSR-ID) and to assess construct
validity of the SSR-ID by showing its association with sleep parameters
measured by actigraphy.
Study design
We will use an observational study in which a newly developed self-report sleep
questionnaire is compared to sleep quality as measured with actigraphy
Study burden and risks
wearing the actiwatch might be experienced as annoying and troublesome for a
few people.
Every time the patient wakes up the button should be pushed. For participants
that are fully independent, it might be a challenge not to forget to push this
button
Daily questionnaires will be filled in by the participants every morning for
seven days. This requires several minutes a day and some effort and attention
of the participants.
In rare cases, the Actiwatch has caused eczema at the wrist around the device
Doctor Molewaterplein 50
Rotterdam 3015 GJ
NL
Doctor Molewaterplein 50
Rotterdam 3015 GJ
NL
Listed location countries
Age
Inclusion criteria
mild intellectual disability
Exclusion criteria
People with spasms.
people with known destructive behavior directed at property
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 | NL47495.078.14 |