EpilepsyNCT07885826
Prospective Longitudinal Study of Sleep, Brain Activity, and Plasma Analyses in Patients Undergoing Epilepsy Surgery
An observational study of Epilepsy and Sleep, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Sleep, Drug Resistant Epilepsy
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 21 Sep 2026to 1 Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults aged ≥18 years who have been offered and accepted epilepsy surgery following a clinical decision at the epilepsy surgery conference at Skåne University Hospital.
- Ability to provide informed consent.
- Healthy controls: age- and sex-matched adults without a diagnosis of epilepsy or a diagnosed sleep disorder, and able to provide informed consent.
Who cannot join
- Inability to provide informed consent.
- Inability to complete the study assessments, for example due to cognitive impairment or another medical condition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Skåne University Hospital
Lund, Skåne County, 22185
Damla Özbek Cetinkaya, MD, Damla.OzbekCetinkaya@skane.se
Christine Ekdahl Clementson, MD, PhD
About this study
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.
Read more
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.
- Conditions
- Epilepsy, Sleep, Drug Resistant Epilepsy, Epilepsy Sleep, Surgery
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy Surgery Group | 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 Control Group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start21 Sep 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885826
- Sponsor's protocol ID
- 2026-03896-01
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No