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NCT Number: NCT05794295

Sleep Architecture & Cognition in Focal Epilepsy

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.

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Key information

Conditions

Focal Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Temitayo Oyegbile-Chidi, MD

CONTACT

916-318-3111

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acoustic Stimulation (AS)

Other

Acoustic Stimulation will be administered while participants have their sleep monitored.

Sham stimulation

Other

No stimulation will be administered while participants have their sleep monitored.

Primary outcomes

  1. Stanford Sleepiness Scale

    Time frame: participant completes over one week post EMU stay

    Alertness Test; charts how alert a participant feels for up to 18 hours of the day for 7 days; scale is from 1-7 with higher scores meaning more sleepiness; abnormal is 4 and above

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: screening

    used to measure quality and patterns of sleep in adults

  3. Epworth Sleepiness Scale

    Time frame: screening

    subjective measure of a patient's sleepiness; scores are from 0-24 with higher scores meaning more sleepiness; abnormal is 10 and above

  4. Karolinska Sleepiness Scale / Sleep Diary

    Time frame: screening

    Self-administered indication of sleepiness; scores are from 1-9 with higher scores meaning more sleepiness; abnormal is 7 and above

  5. Vigor Affect Visual Analog Scale

    Time frame: screening

    self-administered assessment of mood; scores are from 0-10; depending on the question, higher score can mean more sleepiness or less sleepiness

Study contacts

Contact information is provided by the study sponsor or research team.

Temitayo Oyegbile-Chidi, MD

CONTACT

[email protected]

916-318-3111

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Apr 3, 2023
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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