Sleep Architecture & Cognition in Focal Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acoustic Stimulation (AS), SHAM Stimulation.
- Who it may be relevant to
- Registry conditions: Focal Epilepsy. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Focal Epilepsy (FE) patients and healthy controls will wear an actigraph at home for one week and a home sleep study device at home for one night. Participants will then undergo two nights of testing (at least one week apart) at California Sleep Solutions (CSS) in Sacramento, CA. During the overnight stays, participants will have EEG leads placed and possibly a headband. They will undergo cognitive testing before they go to sleep and again in the morning. During one night of testing, sounds will be played in the room (acoustic stimulation). The sounds should not wake the participants.
Detailed description
This study will investigate the interconnections between sleep physiology and cognitive deficits in FE and will provide essential pilot data for an interventional trial to characterize the comprehensive effects of AS/ES on sleep and cognition in FE. The long-term goal of this project is to leverage the connections between sleep, behavior, and neural network activity to develop and implement tailored cognitive and sleep interventions for individuals with epilepsy.
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.
Interventions
- Other Acoustic Stimulation (AS)
Acoustic Stimulation will be administered while participants have their sleep monitored. - Other SHAM Stimulation
No stimulation will be administered while participants have their sleep monitored.
Primary outcome measures
- Stanford Sleepiness Scale [Time frame: participant completes over one week post EMU stay]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: screening]
- Epworth Sleepiness Scale [Time frame: screening]
- Karolinska Sleepiness Scale / Sleep Diary [Time frame: screening]
- Vigor Affect Visual Analog Scale [Time frame: screening]
Eligibility criteria
Inclusion criteria
- Age 18 - 40 years of age
- Focal Epilepsy
- Capacity to fully cooperate and follow directions
- no other significant neurological disorders which could affect cognition
Exclusion criteria
- Current use of any medications that can significantly affect cognition
- No severe sleep apnea
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- UC Davis — Sacramento
Identifiers
NCT: NCT05794295 · 2072010