Epilepsy IntractableNCT06581133
Sleep Disruption Pattern - Epilepsy Monitoring Unit
A study testing Alarm system in people with Epilepsy Intractable, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Epilepsy Intractable
- What is being tested?
- Alarm system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Multiple seizures a day based on pre-admission seizure diary
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mays Khweileh, MD contact
About this study
Official title: 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.
- Conditions
- Epilepsy Intractable
- Being tested
- Alarm system
- Keywords
- epilepsy monitoring unit
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alarm systemDevice
Generic alarm system programmed to sound during the night to try to induce arousals from sleep.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1), last day of EMU stay (up to 5 weeks), 1 month after the EMU stay (up to 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy IntractableStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birgit Frauscher, MD PD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581133
- Sponsor's protocol ID
- Pro00115255
- Status last verified
- Sep 2026
- First submitted
- 4 Apr 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing a Structured Sleep Disruption Pattern to Provoke Earlier Seizures During Epilepsy Monitoring Unit Admissions
- ClinicalTrials.gov ID
- NCT06581133
- Acronym / sponsor ID
- Pro00115255
- Conditions
- Epilepsy Intractable
- Keywords
- epilepsy monitoring unit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alarm | Experimental | Device: Alarm systemPatients 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. |
| 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. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Multiple seizures a day based on pre-admission seizure diary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alarm systemGeneric alarm system programmed to sound during the night to try to induce arousals from sleep. | Device | Alarm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mays Khweileh, MD contact
Birgit Frauscher, MD PD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Alarm system in people with Epilepsy Intractable, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birgit Frauscher, MD PD (9196139386, birgit.frauscher@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency during EMU (epilepsy monitoring unit) stay (time frame: 1 month after the EMU stay (up to 9 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.