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Effect of surgical treatment on the sleep quality in people with epilepsy

Effect of surgical treatment on the sleep quality in people with epilepsy - Effect of surgery on sleepquality in people with epilepsy

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41884
Enrollment
30
Registered
2015-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sleep disturbance

Interventions

epilepsy
sleep
surgery

Sponsors

Stichting Epilepsie Instellingen Nederland
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Secondary

MeasureTime frame
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

Primary

MeasureTime frame
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))

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)