The primary aim of this study is to measure the effect of light therapy on mood in depressed Parkinson patients. In addition, we measure the effect of light therapy on sleep, motor functions, circadian rhythms and quality of life.
ID
Source
Brief title
Condition
- Other condition
- Movement disorders (incl parkinsonism)
- Mood disorders and disturbances NEC
Synonym
Health condition
Slaapstoornissen en -afwijkingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the percent change in score on the Hamilton
Depression Rating Scale (HDRS) and Geriatric Depression Scale (GDS-30) between
baseline and end of treatment (immediate effect) and between baseline and six
months of follow-up (enduring effect). In addition, the Numbers Needed to Treat
(NNT) on the basis of dichotomous treatment response (>50% reduction in
HDRS-score immediately after treatment).
Secondary outcome
Secondary outcome measures are the change in score for measures of sleep
(SCOPA-sleep), motor function (UPDRS-III), Quality of Life (WHOQOL-bref, ZBI)
and circadian rhythms (actigraphy, cortisol morning curve and melatonin evening
curve).
Background summary
The quality of life of patients with Parkinson's disease and their caretakers
is mainly influenced by so called non-motor symptoms. This includes
neuropsychiatric consequences of the disease like depression and sleeping
problems. The incidence of depressed mood in patients with Parkinson is
approximately 50%, the incidence for sleeping problems is 90%. These symptoms
are often overlooked and even if recognized, inadequately treated. The
treatment of mood and sleep disturbances in Parkinson patients is hampered by
adverse effects, incomplete responses to the usual treatments and the absence
of specific treatment options for these symptoms in Parkinson's disease. On the
basis of the hypothesis of disturbed functioning of the suprachiasmatic nucleus
in Parkinson's disease it is expected that stimulation of this nucleus by
bright light therapy will result in improved functioning on multiple different
domains: mood, sleep, motor functions, quality of life and circadian rhythms.
Because there are virtually no side effects and the possibility of home
treatment, light therapy is expected to be highly appreciated by the patients.
Study objective
The primary aim of this study is to measure the effect of light therapy on mood
in depressed Parkinson patients. In addition, we measure the effect of light
therapy on sleep, motor functions, circadian rhythms and quality of life.
Study design
Double blind placebo controlled intervention study (RCT) with six months of
follow-up.
Intervention
Treatment consists of twice daily exposure to bright light; 30 minutes in the
morning and evening for the time of three months. Halve of the patients are
exposed to high intensity light (10.000 Lux), the other halve to low intensity
light (200 Lux).
Study burden and risks
Light therapy is a very safe treatment and knows very little adverse effects.
The most important risk, retina damage, will be prevented by complying with
internationally handled exclusioncriteria, to make sure that patients with an
increased light sensitivity are excluded from participation. Light treatment
will be conducted at the patient's home for a period of three months, twice
daily for 30 minutes. During the exposure to the light treatment patients can
sit inside a chair and, for example, read a book. At six specific timepoints
during the study patients are invited to the neuropsychiatric Parkinson
outpatient clinic of of the VU Medical Center for a clinical interview, filling
in of questionnaires and saliva research. Furthermore, at six timepoints
patients are instructed to wear an actometer on the wrist for a period of one
week.
van der Boechorststraat 7
Amsterdam 1081 BT
NL
van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
Diagnosis of Parkinson's Disease
Stably established on psychotropic medication (>4wk) or off medication for >4wk
Exclusion criteria
psychosis
mania
suicidality
medication inducing retinal photosensitivity
retinopathy
having had BLT before
Design
Recruitment
Medical products/devices used
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 | NL39058.029.12 |