Epilepsy; SeizurePRIMENCT05257811
Earbud EEG Feasibility Study
An observational study of Epilepsy; Seizure and Sleep, run by NextSense, Inc. at 1 site in United States.
Trial summary
The goal of this study is to characterize the ability of the NextSense ear-EEG device to detect pathologic electrographic signatures of epilepsy and physiologic signatures of sleep in subjects undergoing simultaneous inpatient continuous EEG monitoring, polysomnography, or ambulatory EEG monitoring at home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy; Seizure, Sleep
- What is being tested?
- NextSense EEG-enabled earbuds
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 25 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Up to 100 patients may be invited to participate in the study. These patients will have previously been referred for admission to the epilepsy monitoring unit for either diagnostic or presurgical cEEG, or for polysomnography by the neurologists/epileptologists of the Emory Neurology Department.
Who may be able to join
- All patients 18 years of age and older admitted to the Epilepsy Monitoring Unit at Emory University Hospital for long-term inpatient scalp or intracranial cEEG monitoring for diagnostic or pre-surgical evaluation, or patients 18 years and older admitted to the Emory Sleep Center at the Brain Health Center for polysomnography.
- To enhance the likelihood of having a sufficient number of enrolled subjects with an adequate number of seizures, investigators may identify patients more likely to have epileptic rather than non-epileptic seizures based on the medical history.
- All patients who are undergoing ambulatory EEG monitoring at home.
Who cannot join
- Inability to safely tolerate earbuds (e.g. antecedent skin breakdown, recent injury to ear).
- Subjects who cannot have all 16 non-midline scalp EEG electrodes placed, since these EEG channels are required to accurately assess the performance of the seizure detection function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Earbud Electrode Electroencephalography System - Initial Feasibility Study
The goal of this study is to characterize the ability of the NextSense ear-EEG device to detect pathologic electrographic signatures of epilepsy and physiologic signatures of sleep in subjects undergoing simultaneous inpatient continuous EEG monitoring, polysomnography, or ambulatory EEG monitoring at home.
Read the detailed description
For nearly half a century, conventional electroencephalography (EEG) has been the standard of care for monitoring cerebral activity, particularly in the clinical domains of epilepsy and sleep disorders. Standard EEG involves highly time, labor, and cost intensive processes and typically requires subjects to be monitored by specially trained staff in the inpatient setting. Existing ambulatory EEG options are limited to about 3 days in duration because of decline in electrode fidelity beyond that timeframe. There is a need for unobtrusive, easy to use, longitudinal monitoring solutions that can extend to the ambulatory setting.
This study will assess whether novel NextSense EEG Earbuds are able to 1) detect seizures of varying types/localizations as well as interictal epileptiform activity (IEA) waveforms compared to simultaneously recorded conventional scalp EEG, or in some cases, intracranial EEG; and 2) detect characteristic electrographic signatures of AASM defined sleep stages compared to simultaneously recorded polysomnography.
- Conditions
- Epilepsy; Seizure, Sleep
- Being tested
- NextSense EEG-enabled earbuds
- Keywords
- electroencephalography, polysomnography
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NextSense EEG-enabled earbudsDevice
Each NextSense EEGBud device includes custom-fit earbuds with biometric sensors to detect EEG, motion (via tri-axial accelerometers), and heart rate. A ring laser scanner is used to capture the unique geometry of each participant's ear and external auditory canal. Digital models of the individual ear scans are generated and used to create custom fit, 3D-printed earbuds. This design process allows for consistent contact with the inner surface of the ear canal, providing high quality signal capture of brain activity, cardiac activity, and eye movements.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use and tolerability validation of EEG earbuds for patients undergoing cEEG monitoring or polysomnography.
Individual tolerance success will be the presence of an interpretable EEG record for at 18 hours a day, for at least three consecutive days. Overall tolerance will be a ≥ 75% ongoing participation rate, i.e. ≤ 25% study "drop-out" rate. Patients will be questioned about the reasons they felt the EEGBuds needed to be removed, in order to improve future tolerance.
Measured: up to 2 weeks
Performance validation of EEG earbuds for patients undergoing cEEG monitoring or polysomnography
Performance validation is measured as sensitivity (true positive) rate as defined as the total number of true detections divided by the total number of seizures; and specificity (false detection rate [FDR]) as defined as 24 x number of false detections divided by the total number of EEG hours, for each test subject. Detections will be classified as "true" or "false" based on majority rule by expert reviewers (classified by ≥ 2/3 of reviewers).
Criteria for Success:
- ≥ 90% of EEG segments deemed "acceptable quality" by expert reviewers
- Overall seizure detection sensitivity of at least 90% and a mean FDR of no more than 5 per 24 hours
- Overall spike detection sensitivity of at least 90% and a mean FDR of no more than 3 per hour
- Overall focal slowing detection sensitivity of at least 75% and a mean FDR of no more than 3 per 24 hours (focal slowing is traditionally more difficult to ascertain so criteria will be slightly less stringent)
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Sep 2019
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy; SeizureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- NextSense, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Daniel Winkel, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257811
- Sponsor's protocol ID
- IRB00090515
- Acronym
- PRIME
- Status last verified
- Nov 2023
- First submitted
- 5 Feb 2022
- Last updated
- 8 Nov 2023
- Results posted
- 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 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Earbud Electrode Electroencephalography System - Initial Feasibility Study
- ClinicalTrials.gov ID
- NCT05257811
- Acronym / sponsor ID
- PRIME / IRB00090515
- Conditions
- Epilepsy; Seizure, Sleep
- Keywords
- electroencephalography, polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- NextSense, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Emory University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 25 Feb 2022 (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.
The goal of this study is to characterize the ability of the NextSense ear-EEG device to detect pathologic electrographic signatures of epilepsy and physiologic signatures of sleep in subjects undergoing simultaneous inpatient continuous EEG monitoring, polysomnography, or ambulatory EEG monitoring at home.
Detailed description
For nearly half a century, conventional electroencephalography (EEG) has been the standard of care for monitoring cerebral activity, particularly in the clinical domains of epilepsy and sleep disorders. Standard EEG involves highly time, labor, and cost intensive processes and typically requires subjects to be monitored by specially trained staff in the inpatient setting. Existing ambulatory EEG options are limited to about 3 days in duration because of decline in electrode fidelity beyond that timeframe. There is a need for unobtrusive, easy to use, longitudinal monitoring solutions that can extend to the ambulatory setting.
This study will assess whether novel NextSense EEG Earbuds are able to 1) detect seizures of varying types/localizations as well as interictal epileptiform activity (IEA) waveforms compared to simultaneously recorded conventional scalp EEG, or in some cases, intracranial EEG; and 2) detect characteristic electrographic signatures of AASM defined sleep stages compared to simultaneously recorded polysomnography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100 patients may be invited to participate in the study. These patients will have previously been referred for admission to the epilepsy monitoring unit for either diagnostic or presurgical cEEG, or for polysomnography by the neurologists/epileptologists of the Emory Neurology Department.
Key inclusion criteria (3 listed)
- All patients 18 years of age and older admitted to the Epilepsy Monitoring Unit at Emory University Hospital for long-term inpatient scalp or intracranial cEEG monitoring for diagnostic or pre-surgical evaluation, or patients 18 years and older admitted to the Emory Sleep Center at the Brain Health Center for polysomnography.
- To enhance the likelihood of having a sufficient number of enrolled subjects with an adequate number of seizures, investigators may identify patients more likely to have epileptic rather than non-epileptic seizures based on the medical history.
- All patients who are undergoing ambulatory EEG monitoring at home.
Key exclusion criteria (2 listed)
- Inability to safely tolerate earbuds (e.g. antecedent skin breakdown, recent injury to ear).
- Subjects who cannot have all 16 non-midline scalp EEG electrodes placed, since these EEG channels are required to accurately assess the performance of the seizure detection function.
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 |
|---|---|---|
| NextSense EEG-enabled earbudsEach NextSense EEGBud device includes custom-fit earbuds with biometric sensors to detect EEG, motion (via tri-axial accelerometers), and heart rate. A ring laser scanner is used to capture the unique geometry of each participant's ear and external auditory canal. Digital models of the individual ear scans are generated and used to create custom fit, 3D-printed earbuds. This design process allows for consistent contact with the inner surface of the ear canal, providing high quality signal capture of brain activity, cardiac activity, and eye movements. | Device | – |
Primary outcome
Ease of use and tolerability validation of EEG earbuds for patients undergoing cEEG monitoring or polysomnography.
Time frame: up to 2 weeks
Individual tolerance success will be the presence of an interpretable EEG record for at 18 hours a day, for at least three consecutive days. Overall tolerance will be a ≥ 75% ongoing participation rate, i.e. ≤ 25% study "drop-out" rate. Patients will be questioned about the reasons they felt the EEGBuds needed to be removed, in order to improve future tolerance.
Performance validation of EEG earbuds for patients undergoing cEEG monitoring or polysomnography
Time frame: up to 2 weeks
Performance validation is measured as sensitivity (true positive) rate as defined as the total number of true detections divided by the total number of seizures; and specificity (false detection rate [FDR]) as defined as 24 x number of false detections divided by the total number of EEG hours, for each test subject. Detections will be classified as "true" or "false" based on majority rule by expert reviewers (classified by ≥ 2/3 of reviewers). Criteria for Success: 1. ≥ 90% of EEG segments deemed "acceptable quality" by expert reviewers 2. Overall seizure detection sensitivity of at least 90% and a mean FDR of no more than 5 per 24 hours 3. Overall spike detection sensitivity of at least 90% and a mean FDR of no more than 3 per hour 4. Overall focal slowing detection sensitivity of at least 75% and a mean FDR of no more than 3 per 24 hours (focal slowing is traditionally more difficult to ascertain so criteria will be slightly less stringent)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- 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. This study is not recruiting at the moment.
Daniel Winkel, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy; Seizure and Sleep, run by NextSense, Inc. 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 8 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of use and tolerability validation of EEG earbuds for patients undergoing cEEG monitoring or polysomnography. (time frame: up to 2 weeks). The study lists 2 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 Nov 2023.