Sleep Disruption Pattern - Epilepsy Monitoring Unit

NCT ID: NCT06581133

Last Updated: 2026-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2027-12-01

Brief Summary

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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

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Conditions

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Epilepsy Intractable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
This is a single blind study and patients will not know which group they are in.

Study Groups

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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.

Group Type EXPERIMENTAL

Alarm system

Intervention Type DEVICE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Alarm system

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Birgit Frauscher, MD PD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Central Contacts

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Birgit Frauscher, MD PD

Role: CONTACT

9196139386

Mays Khweileh, MD

Role: CONTACT

Other Identifiers

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Pro00115255

Identifier Type: -

Identifier Source: org_study_id

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