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
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