Sleep Disruption Pattern - Epilepsy Monitoring Unit
ConditionEpilepsy Intractable
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-60
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Alarm system
DeviceGeneric alarm system programmed to sound during the night to try to induce arousals from sleep.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: AlarmExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Seizure frequency during EMU (epilepsy monitoring unit) stay
Average number of seizures per day, recorded daily during the patient's EMU stay. Measured for all groups of patients.
Time frame
1 month after the EMU stay (up to 9 weeks)2
Duration of EMU (epilepsy monitoring unit) admission
Overall duration (in days) of the EMU admission. Measured for all groups of patients.
Time frame
1 month after the EMU stay (up to 9 weeks)3
Average interictal spike rates
Average number of spike rates, taken from a random segment for each day and night. Measured for all groups of patients.
Time frame
1 month after the EMU stay (up to 9 weeks)4
Change in sleep quality
As determined by changes in Pittsburgh Sleep Quality Index scores. A higher score indicates increased sleep disturbances.
Time frame
Baseline (Day 1), last day of EMU stay (up to 5 weeks), 1 month after the EMU stay (up to 9 weeks)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: