Sleep Disruption Pattern - Epilepsy Monitoring Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alarm system.
- Who it may be relevant to
- Registry conditions: Epilepsy Intractable. Basic parameters: 14 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Introducing a Structured Sleep Disruption Pattern to Provoke Earlier Seizures During Epilepsy Monitoring Unit Admissions
Overview
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
- Device Alarm system
Generic alarm system programmed to sound during the night to try to induce arousals from sleep.
Primary outcome measures
- Seizure frequency during EMU (epilepsy monitoring unit) stay [Time frame: 1 month after the EMU stay (up to 9 weeks)]
- Duration of EMU (epilepsy monitoring unit) admission [Time frame: 1 month after the EMU stay (up to 9 weeks)]
- Average interictal spike rates [Time frame: 1 month after the EMU stay (up to 9 weeks)]
- Change in sleep quality [Time frame: Baseline (Day 1), last day of EMU stay (up to 5 weeks), 1 month after the EMU stay (up to 9 weeks)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06581133 · Pro00115255