Sleep Disruption Pattern - Epilepsy Monitoring Unit

Duke University

Status: Not yet enrolling

Conditions: Epilepsy Intractable

Treatments: Device: Alarm system

Study type: Interventional

Funder types: Other

Identifiers

NCT06581133

Pro00115255

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

Alarm

Experimental group

Description:

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.

Treatment:

Device: Alarm system

Control

No Intervention group

Description:

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.