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Veranderingen van de slaap na epilepsie chirurgie of implantatie van nervus vagus stimulator


- candidate number17611
- NTR NumberNTR4546
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-apr-2014
- Secondary IDsno 
- Public TitleVeranderingen van de slaap na epilepsie chirurgie of implantatie van nervus vagus stimulator
- Scientific TitleEffect of Epilepsy Surgery and effect of Vagus Nerve Stimulator implantion on Sleep in people with epilepsy
- ACRONYM
- hypothesisAfter epilepsy surgery an improvement of the sleep quality and structure can be expected as result of the disappearance or decrease of the daytime and or nocturnal seizures and the reduction of the amount of medication.
After implantation of vagus nerve stimulation an improvement of sleep quality and structure can expected in the persons without obstructive sleep apnea problems
- Healt Condition(s) or Problem(s) studiedEpilepsy, Sleep disorders, Obstructive sleep apnea syndrome
- Inclusion criteriaAdults and adolescents with refractory epilepsy treated in SEIN location Zwolle, who underwent epilepsy surgery or vagus nerve stimulator was implanted.
Before surgery/implantation a full night sleep EEG/PSG recording has been performed.
At least six months after surgery/implantation a full night sleep EEG/PSG has been or will be performed
- Exclusion criteriaDuring EEG/PSG less then six hours of sleep was recorded.
Nocturnal seizures occurred during the night of interest
Educational level of subject was below special elementary education (SBO)
Subject has an history of alcohol or drug abuse during the 1-year period prior to trial participation
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2014
- planned closingdate1-dec-2015
- Target number of participants30
- InterventionsEpilepsy surgery or implantation vagus nerve stimulator as treatment of refractory epilepsy
- Primary outcomeDifferences in sleep quality and sleep structure between recordings before and after epilepsy surgery/VNS implantation
- Secondary outcome- Changes in seizure-frequency before and after epilepsy surgery/ VNS implantation
- Changes in medication before and after epilepsy surgery
- Subjective sleep score of the nightsleep during EEG/PSG
- Timepoints- EEG/PSG performed before epilepsy surgery/VNS implantation
- EEG/PSG performed at least 6 month after epilepsy surgery/VNS implantation
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Th. Gutter
- CONTACT for SCIENTIFIC QUERIES Th. Gutter
- Sponsor/Initiator SEIN
- Funding
(Source(s) of Monetary or Material Support)
SEIN
- Publicationsno publications
- Brief summaryIn Dutch population, the results of epilepsy surgery is good. In about 80 percent of these people a total seizure reduction is seen during the first year after surgery, after 10 years a percentage of 40% rest. The results of epilepsy surgery are mainly measured with seizure reduction. What the effects are on sleep quality in these people is measured in only small cohorts (zanzmera).
The results of Vagus Nerve Stimulator (VNS) implantations is less successful but still in about 70% percent of these people a seizure reduction is seen. Studies of sleep problems in adults with an active partial epilepsy showed a prevalence that was at least twice as high as in controls (de Weerd). Besides anti-epileptic drugs, nocturnal seizures and psychological problems, also complaints caused by for instance obstructive sleep apnoea syndrome (OSAS) can provide poor sleep. Sleep disorders can exist next to the diagnose epilepsy but can also be the result of the diagnose epilepsy. After epilepsy surgery or VNS implantation an improvement of the sleep quality can be expected as result of the disappearance or decrease of the daytime and or nocturnal seizures and the reduction of the amount of medication, only when no obstructive sleep apnea are induced by the VNS. With this study we want to compare the night sleep, both objective and subjective, before and after their surgery, in people with epilepsy.
- Main changes (audit trail)
- RECORD29-apr-2014 - 21-mei-2014


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