Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05794295

Conditions

Focal Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Acoustic Stimulation (AS)

SHAM Stimulation

Study Details

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.

Conditions

Focal Epilepsy

Study ID

NCT05794295

Start date

Jan 24, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Acoustic Stimulation (AS)

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

sham comparator: SHAM Stimulation

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

Interventions

Acoustic Stimulation (AS)

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

SHAM Stimulation

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

Primary outcome measure

  • Stanford Sleepiness Scale [ Time Frame: participant completes over one week post EMU stay ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: screening ]
  • Epworth Sleepiness Scale [ Time Frame: screening ]
  • Karolinska Sleepiness Scale / Sleep Diary [ Time Frame: screening ]
  • Vigor Affect Visual Analog Scale [ Time Frame: screening ]

Central Contacts and Locations

Central contacts

Temitayo Oyegbile-Chidi, MD

916-318-3111oyegbilechidi@health.ucdavis.edu

Locations

UC Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Temitayo Oyegbile-Chidi, MD

916-318-3111

More Information

Sponsor

University of California, Davis

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Epilepsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-08-07.