Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 19 of 19

List	Outcome	Time frame	Description
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	Change in NREM Sleep Spindle Density	Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery	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.
Secondary	Change in Cyclic Alternating Pattern Rate	Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery	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.
Secondary	Exploratory Changes in Plasma Proteomic Profiles	Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery	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.
Secondary	Change in NREM Slow-Wave Activity	Baseline (before surgery), approximately 2 months after surgery, and approximately 6 months after surgery	NREM slow-wave activity measured using EEG spectral power in the delta frequency band (0.5-4 Hz), expressed in µV²/Hz.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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