Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data

Cyberonics, Inc.3 sites in 1 country147 target enrollmentJune 2012

ConditionsEpilepsy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Epilepsy
Sponsor: Cyberonics, Inc.
Enrollment: 147
Locations: 3
Primary Endpoint: Assess product useability
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

April 2014

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cyberonics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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:

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.