Measuring the effects of light therapy during hemodialysis on objective en subjective sleep parameters, sleepiness during dialysis, mood and melatonin rhythm. De results of this pilot study can be used to design a larger study on light therapy in…
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement of van objective sleep parameters, measured by actigraphy.
Secondary outcome
Changes in subjective sleep, melatonin rhythm, sleepiness during hemodialysis
and mood
Background summary
Previous research has shown that many patients with chronic kidney disease
suffer from sleep disturbances. A possible explanation can be found in the
disturbed or insufficient melatonin secretion in patients with chronic kidney
disease. Previously, we have studied the effects of two different interventions
on improvement of sleep in hemodialysis patients: switch from daytime
hemodialysis to nocturnal hemodialysis and administration of exogenous
melatonin. Both interventions led to an improvement of objective and subjective
sleep parameters and a rise in melatonin secretion. In this pilot study, we
propose a third intervention to improve sleep disturbances and mood of
hemodialysis patients: light therapy. Light is one of the strongest cues for
the biological clock to synchronize with the environment. We hypothesize that
exposure to light therapy will reduce sleepiness during dialysis and thereby
improves the circadian sleep/wake rhythm.
Study objective
Measuring the effects of light therapy during hemodialysis on objective en
subjective sleep parameters, sleepiness during dialysis, mood and melatonin
rhythm. De results of this pilot study can be used to design a larger study on
light therapy in patient with chronic kidney disease.
Study design
intervention trial, cross over model, open label
Intervention
All subjects will be exposed to 3 weeks of light therapy during hemodialysis.
The effects will be compared to a 3-week-period without light therapy during
hemodialysis in the same patient (cross over model)
Study burden and risks
Measurements will take place at 3 moments during the study: at start, end of
light period and end of dark period.
Measurements are non-invasive.
Possible benefit of the participants includes improvement of sleep, mood and
melatonin rhythm.
List of participant activities:
- objective sleep measurement (actigraphy): 3 x 5 days
- melatonin curve in saliva: collection of 3 x 5 saliva samples at 7, 9, 11 pm
and 0 and 7 am
- morningness-eveningness questionnaire: 1x
- Epworth sleepiness scale: 3x
- Mood questionnaire (HAMD6-questionnaire): 3x
- Karolinska sleepiness scale: 6x
Postbus 1502
3800 BM Amersfoort
Nederland
Postbus 1502
3800 BM Amersfoort
Nederland
Listed location countries
Age
Inclusion criteria
- hemodialysis patient
- age 18-85 years
- good understanding and knowledge of dutch language
- informed consent
- subjective sleep disturbance
- intermediate score on morningness-eveningness questionnaire
Exclusion criteria
- severe co-morbidity (neurological, psychiatric, eye diseases, e.g.blindness) that, according to the investigator, impedes the study
- use of melatonin/hypnotics (wash out period before inclusion at least 1 week)
- use of drugs that induce photosensitivity
- active daily programme (job or study) during the day
- jet lag or >1 time zone in the last week
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 |
|---|---|
| ClinicalTrials.gov | NCT01064544 |
| CCMO | NL31080.100.09 |