EpilepsyNCT03207685
Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System
A study testing Additional Seizure Monitoring in people with Epilepsy, run by Empatica, Inc. at 2 sites in 2 countries.
Trial summary
To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU). Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Additional Seizure Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Jun 2017to Jan 2022
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients with a history of convulsive seizure (as defined above) who are admitted to a hospital for routine vEEG monitoring related to seizures. Patients who are expected to have a convulsive seizure during their monitoring based on interpretation of clinical history.
Who cannot join
- Patients who are not expected to have their typical convulsive seizure during the course of their hospital admission (i.e. expected reduction due to anti-epileptic drugs during hospital admission).
- Women who are pregnant.
- Patients who are known or suspected to have a history of PNES only.
- Patients with known allergic reactions to nickel or stainless steel
- Infants who were born pre-term and may not have fully developed skin
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
NYU Langone Medical Center
New York, New York, 10016
Italy1 site
Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit
Roma, 00165
About this study
Official title: Characterizing Generalized Seizure Detection And Alerting In The Epilepsy Monitoring Unit With The Empatica Embrace Watch And Smartphone-Based Alert System
To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).
Read the detailed description
To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).
Subjects will be fit with an Embrace device upon admittance into the EMU. The Embrace system will be used in conjunction with the EMU standard care practices to monitor the subject during the subject's stay. EMU standard care practices will not be impacted by the Embrace system, but rather the Embrace will be used to supplement the EMU monitoring. The events detected by Embrace will later be compared to the gold standard results of the video EEG.
A convulsive seizure (CS) is defined for the purpose of this study as any seizure with non-facial motor activity involving one or both upper and/or lower extremities that has repetitive motor activity (rhythmic motor movements).
- Conditions
- Epilepsy
- Being tested
- Additional Seizure Monitoring
- Keywords
- Epilepsy, Epilepsy Monitoring Unit, EMU, Seizure, Seizure Detection
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional Seizure MonitoringDevice
Embrace could offer an additional layer of seizure monitoring
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Other | This is a single arm study With a device intervention of Additional Seizure Monitoring Receives: Device: Additional Seizure Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Video-EEG to Embrace System
Lower bound of 95% confidence interval of the positive percent agreement (PPA) greater than 70%, as determined in comparison to Video-EEG adjudicated by 3 independent expert reviewers. A majority rules approach is used to identify convulsive seizures.
Measured: 6 months
Secondary outcomes (4)
Alarm System Comparison
Lower bound of 95% confidence interval of the positive percent agreement (PPA) greater than 70%, as determined in comparison to standard alarm system available in EMU.
Measured: 6 months
False Alarm Rate Tolerability
70% of the EMU staff that use the Embrace consider the false alarm rate to be neutral or better in tolerability based on a survey.
Measured: 6 months
Patient Care Improvement Measure
Embrace maintains or improves the level of patient care, as defined by a survey given to the EMU staff.
Measured: 6 months
Embrace System Usability
Usability of the device perceived by the users (Patients and EMU staff).
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 posted5 Jul 2017
- Study start30 Jun 2017
- Primary completion15 Jan 2019
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Empatica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosalind W Picard, Sc.D., Principal investigator, Empatica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207685
- Sponsor's protocol ID
- 2016-002
- Status last verified
- Feb 2021
- First submitted
- 29 Jun 2017
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Generalized Seizure Detection And Alerting In The Epilepsy Monitoring Unit With The Empatica Embrace Watch And Smartphone-Based Alert System
- ClinicalTrials.gov ID
- NCT03207685
- Acronym / sponsor ID
- 2016-002
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Epilepsy Monitoring Unit, EMU, Seizure, Seizure Detection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Empatica, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- Jan 2022 (estimated)
- First posted
- 5 Jul 2017 (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 safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).
Detailed description
To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).
Subjects will be fit with an Embrace device upon admittance into the EMU. The Embrace system will be used in conjunction with the EMU standard care practices to monitor the subject during the subject's stay. EMU standard care practices will not be impacted by the Embrace system, but rather the Embrace will be used to supplement the EMU monitoring. The events detected by Embrace will later be compared to the gold standard results of the video EEG.
A convulsive seizure (CS) is defined for the purpose of this study as any seizure with non-facial motor activity involving one or both upper and/or lower extremities that has repetitive motor activity (rhythmic motor movements).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | Other | Device: Additional Seizure MonitoringThis is a single arm study With a device intervention of Additional Seizure Monitoring |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients with a history of convulsive seizure (as defined above) who are admitted to a hospital for routine vEEG monitoring related to seizures. Patients who are expected to have a convulsive seizure during their monitoring based on interpretation of clinical history.
Key exclusion criteria (5 listed)
- Patients who are not expected to have their typical convulsive seizure during the course of their hospital admission (i.e. expected reduction due to anti-epileptic drugs during hospital admission).
- Women who are pregnant.
- Patients who are known or suspected to have a history of PNES only.
- Patients with known allergic reactions to nickel or stainless steel
- Infants who were born pre-term and may not have fully developed skin
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 |
|---|---|---|
| Additional Seizure MonitoringEmbrace could offer an additional layer of seizure monitoring | Device | All Subjects |
Primary outcome
Comparison of Video-EEG to Embrace System
Time frame: 6 months
Lower bound of 95% confidence interval of the positive percent agreement (PPA) greater than 70%, as determined in comparison to Video-EEG adjudicated by 3 independent expert reviewers. A majority rules approach is used to identify convulsive seizures.
4 secondary outcomes
Alarm System Comparison
Time frame: 6 months
False Alarm Rate Tolerability
Time frame: 6 months
Patient Care Improvement Measure
Time frame: 6 months
Embrace System Usability
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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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.
Rosalind W Picard, Sc.D. principal investigator
Empatica, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional Seizure Monitoring in people with Epilepsy, run by Empatica, Inc. at 2 sites in 2 countries.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Italy. 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?
Results are not available in the source record.
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 Embrace System (time frame: 6 months). 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 2 Feb 2021.