NCT01626599CompletedNot Applicable
Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cyberonics, Inc.
- Enrollment
- 147
- Locations
- 6
- Primary Endpoint
- Assess product useability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Assess product useability
Other
All subjects participate in the same arm. This arm completes the primary objective of product usability.
Intervention: ProGuardian (Device)
Outcomes
Primary Outcomes
Assess product useability
Time Frame: 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 Outcomes
- Collect ECG and accelerometer data; device wearability; and evaluate adverse events.(Up to 7 nights/7 days)
Investigators
Study Sites (6)
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