Epilepsy Intractable
Conditions
Keywords
epilepsy monitoring unit
Brief summary
Epilepsy affects millions worldwide, with 40% of patients experiencing uncontrolled seizures despite medication. Comprehensive epilepsy centers recommend continuous video-electroencephalography monitoring to define seizure type and distinguish mimickers. This process, however, is resource-intensive, with lengthy hospital stays. The investigators' recent study identified a heightened association between arousals and epileptic activity in drug-resistant focal epilepsy patients. Building on these findings, the investigators aim to explore whether disrupting sleep with an alarm system triggers earlier occurrence of seizures, potentially offering insights to reduce hospital stay durations in epilepsy monitoring units.
Interventions
DEVICEAlarm system
Generic alarm system programmed to sound during the night to try to induce arousals from sleep.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
This is a single blind study and patients will not know which group they are in.
Intervention model description
During their epilepsy monitoring unit (EMU) admission, patients will be divided into either the alarm group or the control group. Patients in the alarm group will have an alarm system placed in their room, scheduled to sound at several timepoints during the night. This intervention will be conducted throughout the whole EMU admission. Patients in the control group will have an alarm system placed in their room, but the alarm system will not sound during any of the nights during their EMU admission.
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 14 to 60 years * EMU monitoring for presurgical evaluations * Average 2-3 seizures per week based on pre-admission seizure diary * Sleep as a known seizure trigger
Exclusion criteria
\- Multiple seizures a day based on pre-admission seizure diary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizure frequency during EMU (epilepsy monitoring unit) stay | 1 month after the EMU stay (up to 9 weeks) | Average number of seizures per day, recorded daily during the patient's EMU stay. Measured for all groups of patients. |
| Duration of EMU (epilepsy monitoring unit) admission | 1 month after the EMU stay (up to 9 weeks) | Overall duration (in days) of the EMU admission. Measured for all groups of patients. |
| Average interictal spike rates | 1 month after the EMU stay (up to 9 weeks) | Average number of spike rates, taken from a random segment for each day and night. Measured for all groups of patients. |
| Change in sleep quality | Baseline (Day 1), last day of EMU stay (up to 5 weeks), 1 month after the EMU stay (up to 9 weeks) | As determined by changes in Pittsburgh Sleep Quality Index scores. A higher score indicates increased sleep disturbances. |
Contacts
CONTACTBirgit Frauscher, MD PD
CONTACTMays Khweileh, MD
PRINCIPAL_INVESTIGATORBirgit Frauscher, MD PD
Duke University
Outcome results
None listed