NCT05794295

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
25mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jan 2025Jun 2028

First Submitted

Initial submission to the registry

February 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 24, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

February 28, 2023

Last Update Submit

July 16, 2025

Conditions

Focal Epilepsy

Keywords

Epilepsy

Outcome Measures

Primary Outcomes (5)

  • Stanford Sleepiness Scale

    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

    participant completes over one week post EMU stay

  • Pittsburgh Sleep Quality Index (PSQI)

    used to measure quality and patterns of sleep in adults

    screening

  • Epworth Sleepiness Scale

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

    screening

  • Karolinska Sleepiness Scale / Sleep Diary

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

    screening

  • Vigor Affect Visual Analog Scale

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

    screening

Study Arms (2)

Acoustic Stimulation (AS)

ACTIVE COMPARATOR

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

Other: Acoustic Stimulation (AS)

SHAM Stimulation

SHAM COMPARATOR

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

Other: SHAM Stimulation

Interventions

Acoustic Stimulation (AS)OTHER

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

Acoustic Stimulation (AS)
SHAM StimulationOTHER

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

SHAM Stimulation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 - 40 years of age
  • Focal Epilepsy
  • Capacity to fully cooperate and follow directions
  • no other significant neurological disorders which could affect cognition

You may not qualify if:

  • Current use of any medications that can significantly affect cognition
  • No severe sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Epilepsies, PartialEpilepsy

Interventions

Acoustic Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSensory Art TherapiesComplementary TherapiesPhysical StimulationInvestigative Techniques

Central Study Contacts

Temitayo Oyegbile-Chidi, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be aware of whether they have acoustic stimulation or sham stimulation. They will be asleep while they are monitored.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study is a parallel design with FE patients and healthy controls.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

April 3, 2023

Study Start

January 24, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2028

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)