Sleep Architecture & Cognition in Focal Epilepsy

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT05794295
Status
Recruiting
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Conditions

  • Focal Epilepsy

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 24, 2025
Status verified
Jul 2025
Primary completion
Dec 1, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

Stanford Sleepiness Scale [ Time Frame: participant completes over one week post EMU stay ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC DavisSacramentoCalifornia95817
Temitayo Oyegbile-Chidi, MD
916-318-3111

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By research site
UC Davis· Sacramento, CA

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