An observational study in Epilepsy, Sleep and Drug Resistant Epilepsy, sponsored by Region Skane. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Region Skane · Observational
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:
Participants undergoing epilepsy surgery will complete the assessments before surgery and approximately 2 and 6 months after surgery.
At each assessment, participants will:
The sleep recordings will be used to study several aspects of sleep, including:
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.
1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.
This study's planned enrollment of 40 is below the median of 101 across 536 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Region Skane is the lead sponsor of 382 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with drug-resistant epilepsy who have been selected for epilepsy surgery as part of routine clinical care at Skåne University Hospital, Lund, Sweden. The study also includes healthy adult controls matched to the patient group by age and sex.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adults with drug-resistant epilepsy who are scheduled to undergo epilepsy surgery as part of routine clinical care. Participants will undergo study assessments before surgery and approximately 2 and 6 months after surgery.
Healthy adults matched to the epilepsy surgery group by age and sex. Participants will undergo a single study assessment to provide reference data for comparison with the epilepsy surgery group.
Change in Polysomnography-Derived Sleep Efficiency
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Polysomnography-Derived Total Sleep Time
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Polysomnography-Derived Sleep Stage Distribution
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Polysomnography-Derived Wake After Sleep Onset
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Polysomnography-Derived Arousal Index
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery.
Change in Actigraphy-Derived Total Sleep Time
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Actigraphy-Derived Sleep Efficiency
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Actigraphy-Derived Sleep Timing Variability
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Correlation Between PSG-Derived Sleep Efficiency and Weekly Seizure Frequency
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Insomnia Severity Index (ISI) Total Score
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Hospital Anxiety and Depression Scale (HADS) Depression Score
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Total Score
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Weekly Epileptic Seizure Frequency
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.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in NREM Sleep Spindle Density
Sleep spindle density during NREM sleep, quantified from polysomnography EEG recordings as the number of detected sleep spindles per minute of NREM sleep (spindles/min). Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in Cyclic Alternating Pattern Rate
Cyclic alternating pattern (CAP) rate assessed from NREM sleep EEG recordings, expressed as the percentage (%) of NREM sleep time occupied by CAP sequences. Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Exploratory Changes in Plasma Proteomic Profiles
Relative abundance of individual plasma proteins measured using proteomic analysis, expressed as normalized protein abundance values (arbitrary units). Changes from baseline to approximately 2 and 6 months after epilepsy surgery will be assessed for each quantified protein.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Change in NREM Slow-Wave Activity
NREM slow-wave activity measured using EEG spectral power in the delta frequency band (0.5-4 Hz), expressed in µV²/Hz.
Time frame: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2029, 38 months later.
Of 190 non-industry observational studies under Epilepsy, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 179. This study's planned 38 months is below that.
Counting every sponsor, half of 228 studies reached it within 59 months; a quarter within 29 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.