Sleep Architecture & Cognition in Focal Epilepsy

Last updated: April 21, 2025
Sponsor: University of California, Davis
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Seizure Disorders

Treatment

SHAM Stimulation

Acoustic Stimulation (AS)

Clinical Study ID

NCT05794295
1737425
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Current use of any medications that can significantly affect cognition

  • No severe sleep apnea

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: SHAM Stimulation
Phase:
Study Start date:
February 01, 2025
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • UC Davis

    Sacramento, California 95817
    United States

    Active - Recruiting

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