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NOT YET RECRUITING
NCT07885826

Prospective Longitudinal Study of Sleep, Brain Activity, and Plasma Analyses in Patients Undergoing Epilepsy Surgery

Sponsor: Region Skane

View on ClinicalTrials.gov

Summary

The goal of this observational study is to understand how sleep and brain activity change after epilepsy surgery in adults with drug-resistant epilepsy. Drug-resistant epilepsy means that seizures continue despite treatment with appropriate medications. The study will investigate whether changes in sleep and brain activity are related to seizure control, sleep quality, and quality of life after surgery. The main questions it aims to answer are: * How do sleep patterns and brain activity change after epilepsy surgery? * How are changes in sleep and brain activity related to seizure control and quality of life? * Do sleep patterns after surgery become more like those of healthy adults? * How are changes in blood proteins related to sleep, brain activity, and seizure control? Researchers will follow 30 adults undergoing epilepsy surgery. Their sleep will be compared with that of 10 healthy adults of similar age and sex. Healthy participants will complete the study assessments once. Participants undergoing epilepsy surgery will complete the assessments before surgery and approximately 2 and 6 months after surgery. At each assessment, participants will: * Wear a small device (actigraph) on their wrist for about 2 weeks to measure sleep and activity and keep a sleep diary. * Spend 2 consecutive nights at a patient hotel while their sleep and brain activity are recorded using polysomnography (PSG), a test that measures sleep, breathing, and brain activity. * Answer questionnaires about sleep quality, insomnia, mood, and quality of life. * Provide blood samples for research. Researchers will also collect information about seizure frequency, medications, and medical history. The sleep recordings will be used to study several aspects of sleep, including: * Sleep architecture: how much time participants spend in different stages of sleep and how often their sleep is interrupted. * Sleep spindles and slow oscillations: patterns of brain activity during sleep that are involved in how the brain processes and organizes information. * Cyclic alternating pattern (CAP): a measure of brief changes in brain activity during sleep that can provide information about sleep stability. * Epileptiform activity: abnormal electrical activity in the brain that may be associated with epilepsy and can occur during sleep. Researchers will also analyze proteins in blood samples to explore whether biological changes are related to sleep and seizure outcomes. Epilepsy surgery and other medical treatments will be decided by the participants' treating healthcare teams, independently of this study. The study will observe changes before and after surgery without assigning participants to a treatment.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2026-09-21

Completion Date

2030-12-01

Last Updated

2026-10-21

Healthy Volunteers

Yes

Locations (1)

Skåne University Hospital

Lund, Skåne County, Sweden