Patient-self-adaptive system for detection, recording and alert to caregivers of night-time seizures, linked to private cloud platform for patient tracking and big data exploitation.

Project Information

SEIZSAFE

Grant agreement ID: 726947

DOI

10.3030/726947

Project closed

EC signature date 4 May 2016

Start date 1 June 2016

End date 28 February 2019

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 856 375,00

EU contribution

€ 599 462,50

Coordinated by

ENCORE LAB SL
Spain

Periodic Reporting for period 3 - SEIZSAFE (Patient-self-adaptive system for detection, recording and alert to caregivers of night-time seizures, linked to private cloud platform for patient tracking and big data exploitation.)

Reporting period: 2018-06-01 to 2019-02-28

Summary of the context and overall objectives of the project

Epilepsy is a neurological disorder suffered by around 50 million people worldwide. People affected by seizures, disregarding the disease or syndrome triggering them, tend to have more physical problems (such as fractures and bruising) as well as higher rates of sudden death if they are not properly assisted when seizures occur. They need prompt assistance when experiencing convulsions because there is a risk for them of being injured or having a cardiac arrest. Caregivers (usually patients’ relatives) reduce this risk by being alert and applying techniques such as holding the patients, putting them in a certain stance or providing them with the prescribed drugs.

The situation worsens significantly when generalized seizures occur during the night-time and caregivers cannot assist patients because they are sleeping. Caregivers (especially relatives) are highly concerned about a patient having a deadly episode so they usually sleep in the same room, staying alert all night. This leads to several inconveniences related to interference with their normal lives such as loss of privacy, bad resting, and thus higher risk for patients. It has been shown that 20% of people affected by epilepsy suffer seizures at night-time.

There are already devices designed to monitor patients and alert when they suffer seizures. However, these systems are expensive, inaccurate and/or intrusive, so patients refuse to use them because they feel uncomfortable and caregivers do not trust them, and so both feel deceived and frustrated. Thus, the main problems to solve are:

- Problem 1: Accuracy of the detection systems: sensors and algorithms. Sensors are not always located at the best places: smartwatches cannot detect leg shaking, mattress sensors do not detect mild seizures, etc. Algorithms need to improve to identify patients’ different seizure patterns.
- Problem 2: Intrusiveness of the devices. Most sensors are attached to patients’ bodies, so they are extremely uncomfortable to wear, especially while sleeping. They can also be detached without patients realizing it.
- Problem 3: High price. Most systems for seizure detection are too expensive for patients.
- Problem 4: Lack of data about epileptic seizures. Researchers and clinicians do not have enough information to properly address epilepsy.

SeizSafe has been designed in collaboration with patient associations to solve these problems by providing a non-intrusive reliable system at an affordable price.

SeizSafe is a system to monitor patients during nighttime and alert their caregivers when a seizure is detected. This way, patients can be assisted on time, minimizing seizures’ risks, and caregivers can rest with the peace of mind of knowing that the system will wake them up when a seizure starts. The new system aims to overcome the drawbacks of the current products in terms of reliability, comfort and price, offering patients and caregivers a solution which fits their needs and meets their expectations.

SeizSafe also allows to share (under patient authorization) information about seizures to their doctors, helping them towards better diagnoses and drug prescription. This information will be ultimately used for medical research purposes in order to improve the efficacy of the epilepsy drugs (for more information see 1.4 Ambition).

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The most important milestones achieved to date are the following:

- The system has been completely redesigned from a central device to two devices so the cables that crossed the bed have been eliminated. For this, different design tests have been carried out and the definitive model has already been chosen. A complete study has been carried out aimed at minimizing manufacturing costs once serial production is started.

- Compliance with national regulations related to the law of protection of personal data.

- Medical Device Classification of Seizsafe. This is a key factor for the commercialization so a company specialized in medical devices was hired to study the most suitable classification.

- Launch of the Seizsafe website. https://www.seizsafe.com/en/ the webpage is only in Spanish and English languages. We are now evaluating if it is worth to translate it to other languages like German, Italian and French. Two explanatory videos have been made https://vimeo.com/181606373 in English and Spanish.

- Seizsafe has started the events of dissemination in fairs and to date has been present in:
- Healthio: http://www.healthio-global.com/
- Malta's ehealth week http://www.ehealthweek.org/
- Watify Matchmaking event: https://ec.europa.eu/growth/tools-databases/dem/watify/
- Eureka week in Barcelona https://www.b2match.eu/eurekainnovation2017
- Epilepsy Information Day In Barcelona (Vall d’hebron)
- It is also planned to attend the International Epilepsy Congress in September this year.

- Vall d'Hebron hospital, international leader of epilepsy clinical trials, has been contacted. The hospital is very interested in validating our device and has highlighted the hospital potential that it has, due to the remarkable increase in telemedicine (this is one of the Pillars of the business plan of Seizsafe)

- Universitatsklinikum Marburg in Germany has shown its interest in validating Seizsafe and now the clinical trial protocol is being studied by the medical team

- M3i, the industry-in-clinic platform of the University Hospital of Munich (UHM), has also shown interest in validating Seizsafe in the university hospital.

- CHU Rennes in France was met during the event organised by Images & réseaux . this event was dedicated to explain to the FI-C3 e-health startups the particularities of the medical sector in France and how to access the market. Although the hospital was very interested, the facilities were not suitable for piloting following our protocol.

- The president of the dravet syndrome foundation https://www.dravetfoundation.eu/ has been contacted. He is very interested in the device (in this disease the seizures are especially frequent) and he has been offered to help us with device validation.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

There are already several products in the market aimed to detect epileptic seizures but their features are significantly weaker than those described for SeizSafe. The main reason is that the existing products do not meet the actual needs of patients and their caregivers, and there is significant room for improving their quality of life.

The main innovative characteristics of SeizSafe are pointed out below.

- Self-learning patient-self-adaptive algorithm for seizure detection.

- Camera and cloud platform for doctors.

- Reduced-cost technology.

- Medical validation.

ENCORE’s focus on improving the quality of life of people affected epilepsy (not only patients), and thus it takes into account three vital aspects:

- Minimizing the risks derived from night-time seizures and improving caregivers’ rest.

- Substantially improving the medical diagnosis and treatment of patients, helping doctors to make the correct adjustments of the medication according to the specific kind of seizure/s that every patient is suffering.

- Providing insightful information to pharmaceutical companies about the efficiency of each drug, combining for the first time information about seizures and patients’ intake of medication.

SeizSafe parts and packaging

SeizSafe detection device.

Logo

Detection device.

Camera device.

Helthio fair

Actual layout of Seizsafe