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van CCT (UK)

van CCT (UK)

Prevalence of Sleep Disturbances in People with Epilepsy and the Effect on Quality of life

- candidate number17977
- NTR NumberNTR4617
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mei-2014
- Secondary IDs  
- Public TitlePrevalence of Sleep Disturbances in People with Epilepsy and the Effect on Quality of life
- Scientific TitlePrevalence of Sleep Disturbances in People with Epilepsy and the Effect on Quality of life
- hypothesisAims:
1. To determine the prevalence of subjective sleep disturbances and the influence on quality of life in people with epilepsy compared to people without epilepsy
2. To explore the factors which contribute to sleep disturbances in people with epilepsy
- Healt Condition(s) or Problem(s) studiedEpilepsy, Sleep disorders
- Inclusion criteria- Adult (age 18 yrs or older)
- Definite diagnosis epilepsy
- Seizure frequency of ≥ 1 per year
- An signed informed consent form
- The patient must be capable of understanding Dutch and filling out questionnaires
- ≤ 2 Anti-Epileptic Drugs
- Exclusion criteria- > 1 year seizure free without AED
- Educational level below special elementary education (SBO)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2014
- planned closingdate1-sep-2014
- Target number of participants250
- InterventionsPeople with epilepsy will be asked to cooperate in this questionnaire study. Questionnaires about their sleep and about quality of life and general health has to filled out. They also have to find people without epilepsy to cooperate in this study as controls.
- Primary outcomePrevalence of sleep disturbances in people with epilepsy treated in general hospital compared to age- and gender matched healthy controls
- Secondary outcomeQuality of life scores in people with epilepsy with sleep disturbances compared to those without sleep disturbances
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator SEIN
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summarySubjective sleep disturbances are more often seen in people with epilepsy as in healthy controls. Questionnaire based study in four Dutch clinics showed a prevalence of sleep disturbances in one third of all people with refractory epilepsy. This was twice as high as in healthy controls. The relation between sleep and epilepsy is two-sided. Sleep disorders like insomnia, restless legs syndrome and obstructive sleep apneu syndrome (OSAS) can result in a lack of sleep. Nocturnal seizures, side-effects of anti-epileptic drugs and psychological of psychiatric problems, all directly related to epilepsy, can also influence sleep quality in people with epilepsy. On the other site, a deprivation of sleep may induce epileptic seizures and quality of life. Several sleep disorders can be expected more often in people with epilepsy. A prevalence of OSAS is estimated in general population in 1-4%, whereas in people with epilepsy a prevalence of about 10-30% is described. Insomnia, with sleep onset insomnia and maintenance insomnia can be expected in about 30 %. The prevalence of sleep maintenance insomnia, measured in a questionnaire study is estimated to be higher in people with epilepsy as in controls (58% vs. 38%). The same study did not show a difference in sleep onset insomnia between both groups. This in contrast with the fact that anxiety and depression are important causes of insomnia in men. The prevalence of periodic limb movement disorder is low in young people and increases during advancing age, with an expected prevalence of 34% in people over the age of 60 years. A higher prevalence in people with epilepsy is measured in a questionnaire study. The prevalence of restless legs syndrome is expected not to differ in people with epilepsy compared with controls.
Most of the studies in sleep disorders in people with epilepsy are performed in people with refractory seizures of in specialized clinics. Also differences in age, intelligence, seizures frequency, nocturnal seizures, classification of epilepsy and use of antiepileptic drugs makes comparison of these findings difficult. The prevalence of sleep disturbances is in people with less severe epilepsy and therefore probably with less side-effects is unknown. The effects of sleep problems on quality of life in this population is also a point of interest.
- Main changes (audit trail)
- RECORD28-mei-2014 - 28-jun-2014

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