Sleep Disruption Pattern - Epilepsy Monitoring Unit

February 9, 2026 updated by: Duke University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alarm
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
Generic alarm system programmed to sound during the night to try to induce arousals from sleep.
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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
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.
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Birgit Frauscher, MD PD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

August 29, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00115255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy Intractable

Clinical Trials on Alarm system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe