Sleep Architecture & Cognition in Focal Epilepsy

NCT ID: NCT05794295

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-24

Study Completion Date

2028-06-30

Brief Summary

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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

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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.

Conditions

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Focal Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a parallel design with FE patients and healthy controls.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants will not be aware of whether they have acoustic stimulation or sham stimulation. They will be asleep while they are monitored.

Study Groups

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Acoustic Stimulation (AS)

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

Group Type ACTIVE_COMPARATOR

Acoustic Stimulation (AS)

Intervention Type OTHER

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

SHAM Stimulation

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

Group Type SHAM_COMPARATOR

SHAM Stimulation

Intervention Type OTHER

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

Interventions

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Acoustic Stimulation (AS)

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

Intervention Type OTHER

SHAM Stimulation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UC Davis

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Temitayo Oyegbile-Chidi, MD

Role: CONTACT

916-318-3111

Facility Contacts

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Temitayo Oyegbile-Chidi, MD

Role: primary

916-318-3111

Other Identifiers

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2072010

Identifier Type: -

Identifier Source: org_study_id

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