Epilepsy IntractableNCT06545643
Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs
A study testing Dreem headband in people with Epilepsy Intractable, run by Duke University at 1 site in United States.
Trial summary
Epilepsy, a prevalent neurological disorder, affects 40% of patients with uncontrolled seizures despite medications. Sleep disturbance exacerbates epilepsy, and vice versa, but existing literature suffers from limitations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy Intractable
- What is being tested?
- Dreem headband
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 Jun 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- At least 2 seizures per week based on clinical notes
- Patients where medications will stay stable over the study period
- 40% of both spikes and spindles are identifiable on the dreem headband based on the screening night
Who cannot join
- Cognitive impairment
- Psychiatric comorbidities which may influence sleep
- No bedpartner/caregiver to observe seizures
- Low agreement (below 60%) between Dreem's sleep scoring and manual scoring will be excluded from the study
- Apnea-hypopnea index of > 10/h
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
Birgit Frasucher, MD PD, birgit.frauscher@duke.edu
About this study
Official title: Personalized Risk Assessment of Seizures Sensitive to Poor Sleep: a Longitudinal Study Using Wearable Electroencephalography Devices
Epilepsy, a prevalent neurological disorder, affects 40% of patients with uncontrolled seizures despite medications. Sleep disturbance exacerbates epilepsy, and vice versa, but existing literature suffers from limitations. Studies conducted in hospital settings provide only brief observation periods and fail to capture the natural sleep environment. Wearable technology offers a promising solution, providing a nuanced understanding of the relationship between seizures and sleep. The Dreem headband, an EEG-based wearable, is well-suited for such studies, offering ease of use and validated accuracy. This technology enables extended observation periods under stable medication conditions, essential for assessing the complex interplay between sleep and epilepsy. By elucidating the impact of sleep on seizures, the researchers seek to identify patient populations where sleep significantly influences seizure susceptibility, ultimately informing personalized epilepsy treatments.
Read the detailed description
The first aim of this study is to investigate how variations in sleep timing, duration, and structure influence seizure risk, particularly in individuals with sleep-sensitive seizures. The investigators will conduct longitudinal EEG assessments to analyze how changes in sleep features correlate with interictal epileptiform discharge rates and seizure occurrences over time.
The second aim is to develop a sleep quality index that predicts individual risk for sleep-sensitive seizures, the Sleep-Sensitive Epilepsy Risk Index (SERI). This index aims to predict an individual's seizure risk associated with disrupted sleep, facilitating personalized and preventative patient care.
- Conditions
- Epilepsy Intractable
- Being tested
- Dreem headband
- Keywords
- epilepsy, sleep, wearable EEG
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dreem headbandDevice
The Dreem headband is an EEG-based wearable tool that can be used to reliably assess the relationship between sleep and epilepsy over extended observation periods.
| Study group | Role | What they receive |
|---|---|---|
| Dreem headband | Experimental | Participants will wear a Fitbit daily and a Dreem headband exclusively at night in their homes over a 21-day period as part of the data collection protocol. Additionally, they will maintain daily sleep and seizure diaries. Receives: Device: Dreem headband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time (sleep macrostructure)
Total sleep time as measured by the Dreem headband
Measured: 21 days
Spike rates per hour (epilepsy marker)
Spikes will be detected by the Dreem headband
Measured: 21 days
Seizure frequency per night (epilepsy marker)
Seizures will be detected by the Dreem headband
Measured: 21 days
Secondary outcomes (10)
Sleep latency (sleep macrostructure)
Sleep latency as measured by the Dreem headband
Measured: 21 days
Wake after sleep onset (sleep macrostructure)
Wake after sleep onset as measured by the Dreem headband
Measured: 21 days
Sleep efficiency (sleep macrostructure)
Sleep efficiency as measured by the Dreem headband
Measured: 21 days
Sleep stage distribution (sleep macrostructure)
Sleep stage distribution as measured by the Dreem headband
Measured: 21 days
Sleep spindle events (sleep microstructure)
Sleep spindles (10-16 Hz; duration 0.5-3 sec) as measured by the Dreem headband
Measured: 21 days
Sleep slow wave events (sleep microstructure)
Slow waves (0.5-4 Hz) as measured by the Dreem headband
Measured: 21 days
Performance the SERI model, as measured by the area under the receiver operating characteristic curve
The Sleep-Sensitive Epilepsy Risk Index (SERI) aims to predict an individual's seizure risk associated with disrupted sleep. A high SERI will indicate a high risk for sleep-sensitive seizures, while a low value will indicate a low risk.
Measured: Up to 2 years after study commencement
Sensitivity of the SERI model
The Sleep-Sensitive Epilepsy Risk Index (SERI) aims to predict an individual's seizure risk associated with disrupted sleep. A high SERI will indicate a high risk for sleep-sensitive seizures, while a low value will indicate a low risk.
Measured: Up to 2 years after study commencement
Specificity of the SERI model
The Sleep-Sensitive Epilepsy Risk Index (SERI) aims to predict an individual's seizure risk associated with disrupted sleep. A high SERI will indicate a high risk for sleep-sensitive seizures, while a low value will indicate a low risk.
Measured: Up to 2 years after study commencement
Performance the SERI model, as measured by F1-score
The Sleep-Sensitive Epilepsy Risk Index (SERI) aims to predict an individual's seizure risk associated with disrupted sleep. A high SERI will indicate a high risk for sleep-sensitive seizures, while a low value will indicate a low risk.
The F1 score ranges from 0 to 1. A value of 0 indicates poor performance, and a value of 1 represents perfect performance.
Measured: Up to 2 years after study commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 May 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will initially undergo a screening night at a sleep lab before being equipped with a Dreem EEG headband and a Fitbit for continuous monitoring of sleep patterns and epileptic activity at home. Over 21 days, participants will wear the Fitbit daily and the Dreem headband exclusively at night as part of the data collection protocol. Additionally, participants will maintain daily sleep and seizure diaries.
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT06545643
- Sponsor's protocol ID
- Pro00115560
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Risk Assessment of Seizures Sensitive to Poor Sleep: a Longitudinal Study Using Wearable Electroencephalography Devices
- ClinicalTrials.gov ID
- NCT06545643
- Acronym / sponsor ID
- Pro00115560
- Conditions
- Epilepsy Intractable
- Keywords
- epilepsy, sleep, wearable EEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 9 Aug 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, a prevalent neurological disorder, affects 40% of patients with uncontrolled seizures despite medications. Sleep disturbance exacerbates epilepsy, and vice versa, but existing literature suffers from limitations. Studies conducted in hospital settings provide only brief observation periods and fail to capture the natural sleep environment. Wearable technology offers a promising solution, providing a nuanced understanding of the relationship between seizures and sleep. The Dreem headband, an EEG-based wearable, is well-suited for such studies, offering ease of use and validated accuracy. This technology enables extended observation periods under stable medication conditions, essential for assessing the complex interplay between sleep and epilepsy. By elucidating the impact of sleep on seizures, the researchers seek to identify patient populations where sleep significantly influences seizure susceptibility, ultimately informing personalized epilepsy treatments.
Detailed description
The first aim of this study is to investigate how variations in sleep timing, duration, and structure influence seizure risk, particularly in individuals with sleep-sensitive seizures. The investigators will conduct longitudinal EEG assessments to analyze how changes in sleep features correlate with interictal epileptiform discharge rates and seizure occurrences over time.
The second aim is to develop a sleep quality index that predicts individual risk for sleep-sensitive seizures, the Sleep-Sensitive Epilepsy Risk Index (SERI). This index aims to predict an individual's seizure risk associated with disrupted sleep, facilitating personalized and preventative patient care.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will initially undergo a screening night at a sleep lab before being equipped with a Dreem EEG headband and a Fitbit for continuous monitoring of sleep patterns and epileptic activity at home. Over 21 days, participants will wear the Fitbit daily and the Dreem headband exclusively at night as part of the data collection protocol. Additionally, participants will maintain daily sleep and seizure diaries.
| Arm | Type | Receives |
|---|---|---|
| Dreem headband | Experimental | Device: Dreem headbandParticipants will wear a Fitbit daily and a Dreem headband exclusively at night in their homes over a 21-day period as part of the data collection protocol. Additionally, they will maintain daily sleep and seizure diaries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- At least 2 seizures per week based on clinical notes
- Patients where medications will stay stable over the study period
- 40% of both spikes and spindles are identifiable on the dreem headband based on the screening night
Key exclusion criteria (5 listed)
- Cognitive impairment
- Psychiatric comorbidities which may influence sleep
- No bedpartner/caregiver to observe seizures
- Low agreement (below 60%) between Dreem's sleep scoring and manual scoring will be excluded from the study
- Apnea-hypopnea index of > 10/h
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 |
|---|---|---|
| Dreem headbandThe Dreem headband is an EEG-based wearable tool that can be used to reliably assess the relationship between sleep and epilepsy over extended observation periods. | Device | Dreem headband |
Primary outcome
Total sleep time (sleep macrostructure)
Time frame: 21 days
Total sleep time as measured by the Dreem headband
Spike rates per hour (epilepsy marker)
Time frame: 21 days
Spikes will be detected by the Dreem headband
Seizure frequency per night (epilepsy marker)
Time frame: 21 days
Seizures will be detected by the Dreem headband
10 secondary outcomes
Sleep latency (sleep macrostructure)
Time frame: 21 days
Wake after sleep onset (sleep macrostructure)
Time frame: 21 days
Sleep efficiency (sleep macrostructure)
Time frame: 21 days
Sleep stage distribution (sleep macrostructure)
Time frame: 21 days
Sleep spindle events (sleep microstructure)
Time frame: 21 days
Sleep slow wave events (sleep microstructure)
Time frame: 21 days
Performance the SERI model, as measured by the area under the receiver operating characteristic curve
Time frame: Up to 2 years after study commencement
Sensitivity of the SERI model
Time frame: Up to 2 years after study commencement
Specificity of the SERI model
Time frame: Up to 2 years after study commencement
Performance the SERI model, as measured by F1-score
Time frame: Up to 2 years after study commencement
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 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Epilepsy Intractable
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Recruiting
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
RecruitingPhase 1
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Epilepsy
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.
Birgit Frauscher, MD PD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dreem headband in people with Epilepsy Intractable, run by Duke University at 1 site in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Total sleep time (sleep macrostructure) (time frame: 21 days). The study lists 3 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 19 Oct 2026.