Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data
- Conditions
- Epilepsy
- Interventions
- Device: ProGuardian
- Registration Number
- NCT01626599
- Lead Sponsor
- Cyberonics, Inc.
- Brief Summary
This study is designed to collect data to support development of a novel product designed to sense changes in heart rate or movement during periods of sleep in people with epilepsy. When a potential seizure is detected, the system sends out an audio-visual notification.
- Detailed Description
This is a prospective, interventional, un-blinded, non-significant risk, multi-site study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
Subjects must meet all of the following inclusion criteria:
- Five (5) years of age or older
- 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.
- 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.
- A self-reported diagnosis of epilepsy.
- Currently taking at least one antiepileptic medication.
Caregivers must meet the following inclusion criteria:
- Eighteen (18) years of age or older
- 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
- Willing and able to complete informed consent and HIPAA authorization.
Subjects are not eligible to be enrolled in the study if they meet any of the following exclusion criteria:
- Any visible skin disorder, condition, or abnormal skin pigmentation which, in the investigators opinion, would interfere with the ability to wear the patch.
- 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.
- Known sensitivity or history of irritation to adhesive tape (Latex) and/or topically applied products
- An implanted defibrillator and/or pacemakers
- Severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
- Pregnant and or nursing women (verified by a urine pregnancy test).
- Currently participating in another clinical study without sponsor approval.
- Caregiver that is unable to read instructions in the English language.
Exclusion Criteria for Caregiver:
- Under 18 years of age
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Assess product useability ProGuardian All subjects participate in the same arm. This arm completes the primary objective of product usability.
- Primary Outcome Measures
Name Time Method Assess product useability Up to 7 nights/7 days This study is designed to collect usability data from the intended use population of people with epilepsy and their caregivers to support development of a novel product designed to capture ECG signals and accelerometer data.
- Secondary Outcome Measures
Name Time Method Collect ECG and accelerometer data; device wearability; and evaluate adverse events. Up to 7 nights/7 days Assess ECG and accelerometer data, device adhesion and dermal response
Trial Locations
- Locations (3)
United States, Texas
🇺🇸San Antonio, Texas, United States
United States, Illinois
🇺🇸Chicago, Illinois, United States
United States, North Carolina
🇺🇸Charlotte, North Carolina, United States