Sleep Disruption Pattern - Epilepsy Monitoring Unit

NCT06581133 | Not Yet Recruiting

• 1 other identifier: Pro00115255
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy Intractable

Keywords

epilepsy monitoring unit

Outcome Measures

Primary Outcomes (4)

• 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.

  1 month after the EMU stay (up to 9 weeks)

• Duration of EMU (epilepsy monitoring unit) admission

  Overall duration (in days) of the EMU admission. Measured for all groups of patients.

  1 month after the EMU stay (up to 9 weeks)

• 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.

  1 month after the EMU stay (up to 9 weeks)

• Change in sleep quality

  As determined by changes in Pittsburgh Sleep Quality Index scores. A higher score indicates increased sleep disturbances.

  Baseline (Day 1), last day of EMU stay (up to 5 weeks), 1 month after the EMU stay (up to 9 weeks)

Study Arms (2)

Alarm

EXPERIMENTAL

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.

Device: Alarm system

Control

NO INTERVENTION

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.

Interventions

Alarm system DEVICE

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

Alarm

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- Multiple seizures a day based on pre-admission seizure diary

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Birgit Frauscher, MD PD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgit Frauscher, MD PD

CONTACT

9196139386; birgit.frauscher@duke.edu

Mays Khweileh, MD

CONTACT

mays.khweileh@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single blind study and patients will not know which group they are in.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: During their epilepsy monitoring unit (EMU) admission, patients will be divided into either the alarm group or the control group. Patients in the alarm group will have an alarm system placed in their room, scheduled to sound at several timepoints during the night. This intervention will be conducted throughout the whole EMU admission. 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.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: September 3, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share