Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-01-24
2028-06-30
Brief Summary
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Detailed Description
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AIM 1: Characterize sleep architecture patterns in Focal Epilepsy (FE) and determine the relationship to cognitive processing.
AIM 2: Determine the effect of Sleep Stimulation (Acoustic and/or electrical - AS/ES) on sleep architecture patterns and cognitive processing in FE.
Aim 1 Hypothesis: Compared to controls, FE patients will exhibit interictal epileptiform discharges (IEDs) as well as reduced sleep spindle density and slow wave power with reduced slow wave sleep spindle oscillations (SW-SSO) coupling.
Aim 1 Hypothesis: Compared to controls, reduced SW-SSO coupling during sleep in FE patients will be associated with poorer memory and attention.
Aim 2 Hypothesis: AS/ES will exhibit greater levels of SW-SSO coupling compared to Sham Stimulation.
Aim 2 Hypothesis: Compared to Sham, AS will show increased connectivity on EEG, and improved memory and attention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Acoustic Stimulation (AS)
Participants in this arm will be exposed to acoustic stimulation while they sleep during a night of monitoring.
Acoustic Stimulation (AS)
Acoustic Stimulation will be administered while participants have their sleep monitored.
SHAM Stimulation
Participants in this arm will not be exposed to any stimulation while they have their sleep monitored for one night.
SHAM Stimulation
No stimulation will be administered while participants have their sleep monitored.
Interventions
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Acoustic Stimulation (AS)
Acoustic Stimulation will be administered while participants have their sleep monitored.
SHAM Stimulation
No stimulation will be administered while participants have their sleep monitored.
Eligibility Criteria
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Inclusion Criteria
* Focal Epilepsy
* Capacity to fully cooperate and follow directions
* no other significant neurological disorders which could affect cognition
Exclusion Criteria
* No severe sleep apnea
18 Years
40 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Locations
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UC Davis
Sacramento, California, United States
Countries
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Central Contacts
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Facility Contacts
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Temitayo Oyegbile-Chidi, MD
Role: primary
Other Identifiers
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2072010
Identifier Type: -
Identifier Source: org_study_id
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