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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Polysomnography-Derived Sleep Efficiency — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Sleep efficiency measured by polysomnography (PSG), calculated as total sleep time divided by time in bed, expressed as a percentage (%). Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Change in Polysomnography-Derived Total Sleep Time — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Total sleep time measured by polysomnography (PSG), expressed in minutes. Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Change in Polysomnography-Derived Sleep Stage Distribution — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Percentage of total sleep time spent in each sleep stage (N1, N2, N3 and REM), measured by polysomnography (PSG). Changes in each sleep stage percentage from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Change in Polysomnography-Derived Wake After Sleep Onset — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Wake after sleep onset (WASO), measured by polysomnography (PSG) and expressed in minutes, will be used as a measure of sleep fragmentation. Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Change in Polysomnography-Derived Arousal Index — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery.
  Arousal index measured by polysomnography (PSG), defined as the number of EEG arousals per hour of total sleep time (arousals/hour), scored according to standard sleep scoring criteria.
• Change in Actigraphy-Derived Total Sleep Time — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Mean nightly total sleep time measured by wrist actigraphy over a 14-day recording period, expressed in minutes per night. Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Change in Actigraphy-Derived Sleep Efficiency — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Mean nightly sleep efficiency measured by wrist actigraphy over a 14-day recording period, calculated as total sleep time divided by time in bed and expressed as a percentage (%). Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Change in Actigraphy-Derived Sleep Timing Variability — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Night-to-night variability in sleep onset time, quantified as the standard deviation of sleep onset times across the 14-day wrist actigraphy recording period and expressed in minutes. Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Correlation Between PSG-Derived Sleep Efficiency and Weekly Seizure Frequency — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Correlation between sleep efficiency measured by polysomnography (PSG), expressed as a percentage (%), and weekly epileptic seizure frequency, expressed as number of seizures per week and collected through weekly patient reports.
• Change in Pittsburgh Sleep Quality Index (PSQI) Global Score — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Change in Insomnia Severity Index (ISI) Total Score — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Insomnia symptom severity will be assessed using the Insomnia Severity Index (ISI). The total score ranges from 0 to 28, with higher scores indicating greater insomnia severity. Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Anxiety symptoms will be assessed using the anxiety subscale (HADS-A) of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Change in Hospital Anxiety and Depression Scale (HADS) Depression Score — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Depressive symptoms will be assessed using the depression subscale (HADS-D) of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe depressive symptoms. Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Change in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Total Score — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Epilepsy-specific quality of life will be assessed using the Quality of Life in Epilepsy Inventory-31 (QOLIE-31). The total score ranges from 0 to 100, with higher scores indicating better quality of life. Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
• Change in Weekly Epileptic Seizure Frequency — Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
  Number of epileptic seizures per week, assessed using weekly patient-reported seizure counts collected through REDCap, expressed as seizures/week. This measure applies to participants with epilepsy.

Trial sites (1)

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