Safety and quality

Safety and quality are our top priority. Our Epi-Care products are approved as medical aids. In addition, the Epi-Care free and Epi-Care mobile devices have been clinically tested by independent researchers and institutions. The scientific studies were published in Epilepsia, the leading medical journal for (clinical) research in the field of epilepsy.

Clinically tested

The Epi-Care technology has been tested in independent scientific studies published in the journal Epilepsia.

• 2013: Detection of generalized tonic–clonic seizures by a wireless wrist accelerometer: A prospective, multicenter study.

• 2018: User‐based evaluation of applicability and usability of a wearable accelerometer device for detecting bilateral tonic–clonic seizures: A field study.

Study on clinical safety and reliability of Epi-Care free

The Epi-Care free epilepsy alarm was clinically tested at the Danish Epilepsy Hospital Filadelfia, the Danish Rigshospital and the Epilepsy Center Bethel in Bielefeld. Based on the clinical tests, physicians determined that the Epi-Care alarm is an important tool for people with tonic-clonic seizures.

Method:

The wireless motion sensor, which is worn on the wrist and detects generalized tonic-clonic seizures, has been tested with adults and teenagers. 73 people participated in the investigation. They wore Epi-Care wristbands and were watched simultaneously by video EEG. During the experiment, which lasted an average of three days, they were constantly monitored and the brain's electrical signals measured. Since Epi-Care free can only register tonic-clonic seizures, people with other types of epilepsy have been excluded from testing.

Results:

The test provided two types of data: information from the EEG and information from Epi-Care free. The analysis and comparison of the data showed that 20 people suffered 39 generalized tonic-clonic epileptic seizures

• Epi-Care free has detected 35 out of 38 seizures.

• In two cases, nurses held people's arms during the seizure, so Epi-Care did not function normally.

• Epi-Care has not registered the seizures in the last two cases.

Conclusion:

Epi-Care detected 91% of all tonic-clonic epileptic seizures. This was the highest score in an accelerometer-based epilepsy alarm worldwide - and still is.

Study on the use of Epi-Care in everyday life

Do the results of reliability, safety and other clinical test also apply when using Epi-Care technology in everyday life outside the hospital? The field study of Meritam, Beniczky and Ryvlin in 2018 investigated this question by means of a questionnaire in which users of Epi-Care free and Epi-Care mobile devices, carers and relatives answered questions about their experiences.

Method:

112 users and users of Epi-Care free and Epi-Care mobile, or their caregivers such as health workers or family members, were sent the questionnaire on personal assessments and experiences of the Epi-Care technology, with 71 people responding. The questionnaire consisted of 10 background questions and 15 questions about the epilepsy alarm. In the majority of the questionnaire, including applicability, quality and usability, statements such as "Overall, I am satisfied with using this device" were met. The answer options consisted of a multilevel response scale from 1 to 7, with 1 standing for "I strongly disagree" and 7 for "I strongly agree".

Results:

Epi-Care technology delivers on its promise. This field study shows that the results measured in 2013 are also valid for everyday life and not only in special test environments. Epi-Care free and Epi-Care mobile register 90% seizures with 0.1 false alarms per day and are thus also applicable in the normal everyday home.

Conclusion:

The Epi-Care technology detects 90%. In 40% fewer injuries caused by seizures occurred. This could be attributed to the fact that carers can be alerted faster with the help of the epilepsy alarm and, for example, can remove dangerous objects from the environment in the event of a seizure.

References:

Beniczky, S., Polster, T., Kjaer, T. W., & Hjalgrim, H. (2013). Detection of generalized tonic–clonic seizures by a wireless wrist accelerometer: A prospective, multicenter study. Epilepsia, 54(4), e58-e61. doi:10.1111/epi.12120

Meritam, P., Ryvlin, P., & Beniczky, S. (2018). User‐based evaluation of applicability and usability of a wearable accelerometer device for detecting bilateral tonic–clonic seizures: A field study. Epilepsia, 59(S1), 48-52. doi:10.1111/epi.14051

False alarms:

Read more on what causes false alarms and how to reduce them.