Primary:• To study the effect of rotigotine on nocturnal hypokinesiaSecondary:• To study the possibility of measuring nocturnal hypokinesia and its severity in a home setting• To correlate improvements in sleep quality by rotigotine with changes in…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Position changes over the night.
Secondary outcome
Objective
• Degree of mobility, measured as the speed of the movements
• Total amount of movements
• Score on the motor symptom scale according to the MDS-UPDRS part III
Subjective
• Nocturnal sleep quality
Excessive daytime sleepiness
• Presence of nocturnal akinesia
Background summary
Parkinson*s disease (PD) is a neurodegenerative disorder that is characterized
with motor symptoms such as hypokinesia, rigidity, tremor and postural
instability. These symptoms can also be present during the night. Half of the
patients with PD have difficulty turning around in bed. This nocturnal
hypokinesia is considered as a possible cause of sleep problems in this
population. The diagnosis nocturnal hypokinesia is based on the clinical
interview. There is a need for a diagnostic devices that measures nocturnal
movements, preferably in the home setting. This device can be used in the
diagnostic trajectory as well in the evaluation of treatment. Recently the
Dynaport Minimod (McRoberts, The Hague) has been developed to register
nocturnal movements. The tri-axial accelerometer has been developed to measure
position changes in the night. A validation study with actigraphy and
polysomnography concluded that the Dynaport MiniMod is a valid an feasible
device for assessing intensity and physical activity and changes of body
position during sleep.
Nocturnal hypokinesia is treated with nocturnal dopamine. Sometimes a
night-time dose of dopaminergics is adequate, but most of the time slow release
dopaminergics are needed. However response fluctuations can negatively
influence the treatment. In these cases continuous dopaminergic stimulation is
needed, such as rotigotine. Rotigotine treats response fluctuations during the
day and studies show that sleep quality measured with questionnaires improves.
If the improvement of sleep quality is caused by improved bed mobility has not
been studied yet.
Study objective
Primary:
• To study the effect of rotigotine on nocturnal hypokinesia
Secondary:
• To study the possibility of measuring nocturnal hypokinesia and its severity
in a home setting
• To correlate improvements in sleep quality by rotigotine with changes in
nocturnal hypokinesia
Study design
We will study patients who will recieve rotigotine as a part of their usual
care. During three nights, nocturnal movements are being registered with
movement sensors, before treatment has started as well as after a stable
medication dose of one month. We will also assess sleep quality with
questionnaires.
Study burden and risks
The rotigotine patches can, like every other drugs, have side-effects. For
rotigotine the most common side-effects are skin reactions on the
administartion place, nausea, dry mouth and desoriëntation. Although de
movement sensor is small, it is possible that it can interfere with the
patients sleep.
Sterkselseweg 65
5591 VE Heeze
NL
Sterkselseweg 65
5591 VE Heeze
NL
Listed location countries
Age
Inclusion criteria
Patients with idiopathic PD
Patients who will start treatment with rotigotine
Hoehn & Yahr stage II - IV
Subjective sleep problems most likely caused by nocturnal hypokinesia
Exclusion criteria
Other significant causes for nocturnal motor symptoms which are not dopamine-responsive
Previous surgery for PD
Mini- mental state examination score < 25
Concurrent hallucination or psychosis
History of skin hypersensitivity to adhesives or other transdermals
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 | NL38851.091.11 |