Epilepsy, Tonic-ClonicNCT05059002
EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System
A study testing Physiological signal monitoring and seizure detection in people with Epilepsy, Tonic-Clonic, run by EpiWatch, Inc. at 1 site in United States.
Trial summary
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (EMU). Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Epilepsy, Tonic-Clonic
- What is being tested?
- Physiological signal monitoring and seizure detection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 31 Oct 2023
- Phase
- Interventional
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admitted to a site EMU for video-EEG monitoring
- Age five and older at the time of enrollment
- Has a clinical history of tonic-clonic (TC) seizures or potential for TC seizures
- Willing and able to comply with study procedures
Who cannot join
- Has participated previously in EpiWatch development studies or contributed any data to the prior development or evaluation of the detector being tested or previous detectors
- Has any condition that would prevent proper wearing of the watch, its free movement during a seizure, or create discomfort from wearing the watch
- Inability or unwillingness to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (EMU).
Read the detailed description
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review, during patient hospitalization in an epilepsy monitoring unit (EMU).
Eligible subjects will be issued an EpiWatch device upon admittance into the EMU. The events detected by the EpiWatch will be compared to TC seizures as determined by epileptologists' interpretation of video-EEG recorded for the subject to determine the effectiveness of EpiWatch in detecting TC seizures. EMU standard care practices will not be modified for subjects.
- Conditions
- Epilepsy, Tonic-Clonic
- Being tested
- Physiological signal monitoring and seizure detection
- Keywords
- Seizure Detection, Seizure, Digital Health
- Medical subject headings
- Epilepsy, Tonic-Clonic, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological signal monitoring and seizure detectionDevice
Data collection and as an adjunct to other methods of seizure monitoring
| Study group | Role | What they receive |
|---|---|---|
| Monitored Subjects | Other | Single arm study of subjects that have been issued an EpIWatch Receives: Device: Physiological signal monitoring and seizure detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of video-EEG to EpiWatch Results for PPA
Lower bound of 95% confidence interval of the positive percent agreement (PPA) > 80%, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.
Measured: 6 months
Comparison of video-EEG to EpiWatch results for FAR
Upper bound of 95% confidence interval of the false alarm rate (FAR) <.71, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.
Measured: 6 months
Secondary outcomes (2)
Pediatric Ambulation Positive Percent Agreement
Estimate the PPA in pediatric participants in ambulation in addition to at rest
Measured: 6 months
Pediatric Ambulation False Alarm Rate
Estimate the False Alarm Rate in pediatric participants in ambulation in addition to rest
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start20 Sep 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Tonic-ClonicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- EpiWatch, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory L Krauss, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059002
- Sponsor's protocol ID
- EPW001
- Status last verified
- May 2024
- First submitted
- 17 Sep 2021
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System
- ClinicalTrials.gov ID
- NCT05059002
- Acronym / sponsor ID
- EPW001
- Conditions
- Epilepsy, Tonic-Clonic
- Keywords
- Seizure Detection, Seizure, Digital Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- EpiWatch, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 28 Sep 2021 (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.
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (EMU).
Detailed description
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review, during patient hospitalization in an epilepsy monitoring unit (EMU).
Eligible subjects will be issued an EpiWatch device upon admittance into the EMU. The events detected by the EpiWatch will be compared to TC seizures as determined by epileptologists' interpretation of video-EEG recorded for the subject to determine the effectiveness of EpiWatch in detecting TC seizures. EMU standard care practices will not be modified for subjects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitored Subjects | Other | Device: Physiological signal monitoring and seizure detectionSingle arm study of subjects that have been issued an EpIWatch |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted to a site EMU for video-EEG monitoring
- Age five and older at the time of enrollment
- Has a clinical history of tonic-clonic (TC) seizures or potential for TC seizures
- Willing and able to comply with study procedures
Key exclusion criteria (3 listed)
- Has participated previously in EpiWatch development studies or contributed any data to the prior development or evaluation of the detector being tested or previous detectors
- Has any condition that would prevent proper wearing of the watch, its free movement during a seizure, or create discomfort from wearing the watch
- Inability or unwillingness to comply with study procedures
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 |
|---|---|---|
| Physiological signal monitoring and seizure detectionData collection and as an adjunct to other methods of seizure monitoring | Device | Monitored Subjects |
Primary outcome
Comparison of video-EEG to EpiWatch Results for PPA
Time frame: 6 months
Lower bound of 95% confidence interval of the positive percent agreement (PPA) > 80%, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.
Comparison of video-EEG to EpiWatch results for FAR
Time frame: 6 months
Upper bound of 95% confidence interval of the false alarm rate (FAR) <.71, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.
2 secondary outcomes
Pediatric Ambulation Positive Percent Agreement
Time frame: 6 months
Pediatric Ambulation False Alarm Rate
Time frame: 6 months
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 4 Feb 2025.
- 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.
Gregory L Krauss, MD principal investigator
Johns Hopkins 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 Physiological signal monitoring and seizure detection in people with Epilepsy, Tonic-Clonic, run by EpiWatch, 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 4 inclusion and 3 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 4 Feb 2025. 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?
Comparison of video-EEG to EpiWatch Results for PPA (time frame: 6 months). 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 4 Feb 2025.