Sleep Disruption Pattern - Epilepsy Monitoring Unit

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.

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Key information

Conditions

Epilepsy Intractable Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alarm system

Device

Generic alarm system programmed to sound during the night to try to induce arousals from sleep.

Primary outcomes

Seizure frequency during EMU (epilepsy monitoring unit) stay

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Birgit Frauscher, MD PD

CONTACT

[email protected]

9196139386

Mays Khweileh, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Introducing a Structured Sleep Disruption Pattern to Provoke Earlier Seizures During Epilepsy Monitoring Unit Admissions

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 3, 2024
Registry last updated: Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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