Sleep Architecture & Cognition in Focal Epilepsy

University of California (UC) Davis

Status: Enrolling

Conditions: Focal Epilepsy

Treatments: Other: SHAM Stimulation; Other: Acoustic Stimulation (AS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05794295

1737425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Acoustic Stimulation (AS)

Active Comparator group

Description:

Participants in this arm will be exposed to acoustic stimulation while they sleep during a night of monitoring.

Treatment:

Other: Acoustic Stimulation (AS)

SHAM Stimulation

Sham Comparator group

Description:

Participants in this arm will not be exposed to any stimulation while they have their sleep monitored for one night.

Treatment:

Other: SHAM Stimulation