Sleep Disruption Pattern - Epilepsy Monitoring Unit
- Conditions
- Epilepsy Intractable
- Interventions
- Device: Alarm system
- Registration Number
- NCT06581133
- Lead Sponsor
- Duke University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- Multiple seizures a day based on pre-admission seizure diary
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alarm Alarm system Patients in the alarm group will have an alarm system placed in their room, scheduled to sound at 4 timepoints during the night (specific timepoints adjusted based on patient's preferred bed times). This intervention will stop when the clinical team has collected sufficient seizures for clinical decision making.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method