The main objective of the study is to examine whether dynamic light has a positive influence on the sleep-wake rhythm, depression, emotional distress and agitation in people with dementia. Healthcare innovations, intended for at home use, are used…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Does the frequency of nightly bedwandering decrease?
Does the duration (minutes) of lying in bed during the night increase?
Secondary outcome
Does the frequency of naps decrease during the day?
Does the duration (minutes) of lying in bed during the day (in minutes)
decrease?
Does the participant receive significantly more light (in lux) when exposed to
biodynamic light?
Do the symptoms of depression improve on the GDS-15?
Do the symptoms of distress improve on the HADS-A?
Do the symptoms of agitation improve on the CMAI?
Do the symptoms of emotional distress of informal caregivers improve on the CSI?
These variables are measured using a wearable in the last week of each
condition that detects movement and a light logger that can record the amount
of lux received per participant.
Background summary
People with dementia are often not easy to live with because of their sleeping
problems, e.g.nightly bedwandering and depression, emotional distress and
agitation. Their irregular sleep-wake rhythm, caused by disturbance of the
biological clock, is one of the main reasons that primary caregivers ask for a
placement in a nursing home.
The sleep-wake rhythm is regulated by the biological clock in the
suprachiasmatic nuclei (SCN), which has an intrinsic cycle of just over 24
hours. The light-dark pattern that falls on the retina of the eye throughout
the day trains the SCN on this 24-hour rhythm and coordinates and stimulates
biological rhythms at the right times of the day and night so that one can live
and survive. Without exposure to a regular, daily pattern of light and dark,
biological rhythms become irregular and threaten our health and well-being
(Carvalho-Boss et al., 2007). In people with dementia, this rhythm can be more
disturbed than in normal aging. The function of the SCN also deteriorates more
strongly in the case of dementia and the aging eye needs more light than a
young eye (Revell & Skene, 2010).
Light therapy, intended to train this rhythm well, offers a promising
nonpharmacological method to regulate sleep-wake rhythm in people with
dementia. Research shows that when sufficiently exposed to light, the
sleep-wake rhythm improves, improves mood and concentration and reduces
agitation (Dowling et al., 2005., Van Someren et al., 1997., Ancoli-Isreal et
al., 2003. Riemersma-van der Lek et al., 2008).
However, research has also shown that people who are getting older are less
likely to go outdoors and that the lighting conditions in nursing homes and
care institutions are insufficient. On average, young people go outside 5 hours
a day, older people 1 hour and people in a nursing home only 1.6 minutes a day.
This means that their biological clock is not sufficiently stimulated (Aarts &
Westerlaken,
2005).
From research by Riemersma- Van Der Lek et al. (2008), Fontaneous Gasio et al.
(2003) and Figueiro et al. (2014) the circadian rhythm and sleep pattern have
improved at a strong light intensity of 1100 Lux and the color temperatures
bright, blue and white light. The colour and intensity of the light is
important. The aging eye tolerates indirectly vertically offered light with
less intensity better. That is why a regular light therapy lamp is not
suitable. Dynamic light has a variable range of light intensity and colour
temperature and follows the rhythm of the day. During the day more blue and
intense light is offered, and in the evening less intense, reddish warm light.
It mimics a 'real life' pattern relative to continuous light intensity.
Study objective
The main objective of the study is to examine whether dynamic light has a
positive influence on the sleep-wake rhythm, depression, emotional distress and
agitation in people with dementia. Healthcare innovations, intended for at home
use, are used in this study. The research is a promotion study and consists of
two separate studies, which are carried out sequentially. The first study has
been realised within a clinical psychiatric department for the elderly of the
GGzE in Eindhoven. This study focuses on people with dementia still living at
home.
This follow-up study is in line with and uses the infrastructure of Innovate
Dementia (www.innovatedementia.eu). With this follow-up study we hope to be
able to make a contribution to the long and pleasant living at home of people
with dementia and to relieve the burden on primary caregivers, by gaining
insight if offering dynamic light leads to an improved sleep rhythm and an
improved mood, less anxiety and less agitation and consequently its effect on
the caregiver distress. Based on a previous research in the clinical setting,
it is expected that the nightly restlessness, wandering, of people with
dementia will decrease. It is also expected that people take fewer naps during
the daytime. This would mean that the sleep rhythm is improved, but also the
quality of life is enhanced if people will be more active during the day.
Finally, we expect that light can reduce medication consumption and that
primary caregivers will have less need for care themselves.
Study design
Participants participate for 16 weeks in this study. Movement data will be
collected during every last week of each condition, in total four weeks,
through a movement sensor that registrates acitvation when someone goes into or
out of bed at any time of the day. This period of 16 weeks is divided into four
periods of 4 weeks (design is ABAB). In one period (B) the person being exposed
to biodynamic lighting by using dynamic light bulbs in each lamp in the
participant's home. The other period (A) dynamic light is not offered, but
normal lighting still is. The participant will participate in both conditions
twice which makes this a strong design. The research design is an ABAB-design.
In addition, a wearable, light logger is used to measure the amount of light
received during the day, in order to measure as objectively as possible the
amount of lux received. The primary caregiver will also wear the lightlogger
every last week. Before the start of the investigation a move test is assessed
to check if the participant is physically able to participate in the study.
After each condition four short questionaires are assessed to registrate the
symptoms of depression, emotional distress and agitation of the client, and the
perceived burden on the informal caregiver. Because a wash-out period of two
weeks is used, both conditions do not influence each other.Before start of the
study mental competence is judged, a short neuropsychological test ((MMSE) is
administrated to determine the cognitive level of the participants, a short
sleeping questionnaire (SCOPA and NPI-Q question nighttime behaviors) is
administrated to determine if participants have nighttime sleeping problems..
Intervention
The intervention consists of exposure to biodynamic light.
This is done by equipping each lamp in the room where the participant is
regularly (at least daily) with dynamic lighting through replacing each light
bulb with a dynamic light bulb, which "plays" a progromma on smartphone or
tablet by means of an app that mimics a light pattern according to a normal
daylight curve. That means more blue colored and more intense light in the
morning and more warm colored, less intense light in the evening, so that the
biological clock adapts to this rhythm.
Study burden and risks
There are no health risks associated with the research.
A possible benefit is that the subject may experience an improved sleeping
pattern and consequently improved wellbeing.
A second possible benefit is that the primary caregiver might experience less
distress due to the improved sleeping pattern of the participant.
When the intervention results in an improvement in sleeping pattern and/or
wellbeing, it can easily be implemented in the homes of people with dementia
and in general mental health care and in homes or hospitals. The benefits for
health and quality of life are expected to far outweigh the costs of this
study. The benefits for society imply a considerable reduction in the burden on
the health care system.
Burden for the patients is investment of time and an adjustment of the light
plan in their home they need to adjust to. After a screening procedure in which
subjects have to undergo a short neuropsychological test and a moventest, the
time investment for subjects (participants and caregivers) is 300-360 minutes
for questionnaires (distributed over 6 meetings in 16 weeks). Before the start
of the adjustment of the lighting at home and the measurements, participants
and caregivers get a meeting of approximately 1 hour to receive specific
instructions related to this procedure and the measurement device. This meeting
will take place in the home situation so this is less burden fort he
participants. The adjustment of the lighting plan will take place in the at
home situation but does not need any investment from the participants.
In sum, the investment of time after screening procedures and instruction
comprises for all subjects 360 minutes.
Dokter Poletlaan 40
Eindhoven 5626 ND
NL
Dokter Poletlaan 40
Eindhoven 5626 ND
NL
Listed location countries
Age
Inclusion criteria
-Diagnosis of dementia
-Score MMSE > 22
-nighttime sleep problems (Scopa night >7, NPI-Q nighttime behaviors question answered with "yes")
-mentally competent
Exclusion criteria
-sleeping disorder, like narcolepsy
-eye problems, like blindness
- physical disabilities (eg wheelchair dependence)
- age under 55 years
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 | NL63355.028.17 |