The primary objective of this study is to evaluate the effect op epilepsy surgery of implantation of a Vagus Nervus Stimulator on the subjective and objective measures of sleep quality. Secondly the differences in sleep quality and sleep…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in polysomnography (PSG) / EEG parameters before and after surgery
(sleep latency, sleep efficiency, wake after sleep onset, sleep architecture
(distribution of all sleep stages))
Secondary outcome
Differences in scores sleep scales (Groninger Sleep Quality) before and after
surgery
Differences in scores on quality of life scales QOLie-31-P(v2), before and
after surgery
Differences in scores on neuropsychological measures of memory (WMS-R), before
and after surgery
Background summary
Earlier studies have shown that people with epilepsy report sleep disturbances
more often than people without epilepsy. There has been a lot of research
regarding the effect of epilepsy surgery on the seizure frequency and quality
of life. Research regarding the objective or subjective changes in sleep
structure after resective surgery or implantation of a VNS has been scarce. By
comparing pre-operative night sleep PSG/EEGs with post-operative night sleep
PSG/EEGs, more knowledge will be gathered on the effect of (total) seizure
reduction on the sleep in people with or cured from epilepsy. Additionally, a
positive effect on quality of sleep and quality of life can be expected after
seizure reduction or seizure freedom.
Study objective
The primary objective of this study is to evaluate the effect op epilepsy
surgery of implantation of a Vagus Nervus Stimulator on the subjective and
objective measures of sleep quality. Secondly the differences in sleep quality
and sleep architecture pre and post surgery will be compared, as well for
subjective measures of sleep, quality of life and memory function of (former)
epilepsy patients.
Study design
Observational study, with a measurement before and after surgery
Study burden and risks
For subjects in this study there are no risks. The burden is for the subjects
the (extra) night sleep recording, to sleep with electodes on head and body
(EEG, ECG, Respiratory and movements) in the hospotal (the same as
pre-surgical). If the results of this study indicate a sleeping disorder the
neurologist of this subject will be informed.
Dr Denekampweg 20
Zwolle 8025BV
NL
Dr Denekampweg 20
Zwolle 8025BV
NL
Listed location countries
Age
Inclusion criteria
An adult (18 years or older) with intractable epilepsy treated in SEIN Zwolle, who underwent resective surgery or had an Vagus Nerve Stimulator or Deep Brain Stimulator implanted.
Before surgery a night sleep PSG/EEG recording is performed. This recording was performed 12 months before surgery at most, recorded a minima of 6 hours of sleep and no nocturnal (secundairy) generalized seizure(s) occured during the night
Exclusion criteria
Using a questionnaire, (which is included in the application, and will be given to prospective participants when asked to participate in this study), we exlude participants who have a(n):
- educational level below special elementary education
- history of alcohol or drug abuse during the 1-year period prior to trial participation (criteria for abuse are implemented from health care clinic Jellinek, specialized in abuse)
- the diagnosis of illnesses that affect sleep, like heart failure, cardiac arrythmias pulmonary disease, or sleeping disorders, existing before the diagnosis of epilepsy was made
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 | NL52147.042.15 |