Clinical trial NCT05794295: Sleep Architecture & Cognition in Focal Epilepsy
Official title: Sleep Architecture & Cognition in Focal Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Focal Epilepsy
Keywords: Epilepsy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a parallel design with FE patients and healthy controls.
Primary purpose: OTHER

Brief summary: 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.

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

Primary outcomes:
measure: Stanford Sleepiness Scale
timeFrame: participant completes over one week post EMU stay
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: screening
measure: Epworth Sleepiness Scale
timeFrame: screening
measure: Karolinska Sleepiness Scale / Sleep Diary
timeFrame: screening
measure: Vigor Affect Visual Analog Scale
timeFrame: screening
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
Study officials:
References: