Sleep Architecture & Cognition in Focal Epilepsy
ConditionFocal Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 - 40 years of age
Focal Epilepsy
Capacity to fully cooperate and follow directions
no other significant neurological disorders which could affect cognition
Disqualifiers
Current use of any medications that can significantly affect cognition
No severe sleep apnea
Trial design
Design model
Parallel
Treatments tested in this trial
Acoustic Stimulation (AS)
Other interventionAcoustic Stimulation will be administered while participants have their sleep monitored.
SHAM Stimulation
Other interventionNo stimulation will be administered while participants have their sleep monitored.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Acoustic Stimulation (AS)Active comparator 1 intervention
Group B: SHAM StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
participant completes over one week post EMU stay2
Pittsburgh Sleep Quality Index (PSQI)
used to measure quality and patterns of sleep in adults
Time frame
screening3
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
Time frame
screening4
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
Time frame
screeningSponsors and contacts
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Source ClinicalTrials.gov