Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cyberonics, Inc.
This is a prospective, interventional, un-blinded, non-significant risk, multi-site study.
Age
5–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Five (5) years of age or older
2. Caregiver capable of understanding and willing to comply with instructions provided in English for proper use of the study device as well as scheduled study visits.
3. Guardian/Parent for subjects less than 18 years or with cognitive limitation that would preclude consent must be willing and able to complete informed consent/and HIPAA authorization.
4. A self-reported diagnosis of epilepsy.
5. Currently taking at least one antiepileptic medication.
1. Eighteen (18) years of age or older
2. Capable of understanding and willing to comply with instructions provided in english for proper use of the study device as well as scheduled study visits
3. Willing and able to complete informed consent and HIPAA authorization.
You may not be if
1. Any visible skin disorder, condition, or abnormal skin pigmentation which, in the investigators opinion, would interfere with the ability to wear the patch.
2. History of chronic dermatological, medical, or physical conditions that would, in the investigators opinion, preclude topical application of the test products and/or influence the outcome of the test.
3. Known sensitivity or history of irritation to adhesive tape (Latex) and/or topically applied products
4. An implanted defibrillator and/or pacemakers
5. Severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
6. Pregnant and or nursing women (verified by a urine pregnancy test).
7. Currently participating in another clinical study without sponsor approval.
8. Caregiver that is unable to read instructions in the English language.
1. Under 18 years of age
2. Not capable of understanding and willing to comply with instructions provided in English for proper use of the study device as well as scheduled study visits
Clareo Health | Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data
