Sleep Disruption Pattern - Epilepsy Monitoring Unit

Not Applicable

Not yet recruiting

• Conditions: Epilepsy Intractable

• 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

Study Timeline

• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-08-29
• Study First Posted: 2024-09-03
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-27
• Study Start: 2025-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.