Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data

Cyberonics, Inc.147 enrolled

Overview

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.

This is a prospective, interventional, un-blinded, non-significant risk, multi-site study.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

147

Conditions

Epilepsy

Interventions

ProGuardianDEVICE

The investigational system is composed of a sensor, patch, hub, and caregiver application. The sensor is applied externally during periods of nocturnal sleep for up to 7 nights. The investigational system: * is not implantable and no surgical procedure is required for a human subject to use the devices; * is not for use in supporting or sustaining a human life; and * is not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health. * Contains skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles.

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subjects must meet all of the following inclusion criteria: 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. Caregivers must meet the following inclusion criteria: 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. Exclusion Criteria: Subjects are not eligible to be enrolled in the study if they meet any of the following exclusion criteria: 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. Exclusion Criteria for Caregiver: 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

Locations (6)

United States, Illinois

Chicago, Illinois, United States

United States, North Carolina

Charlotte, North Carolina, United States

United States, Texas

Austin, Texas, United States

United States, Texas

Houston, Texas, United States

Outcomes

Primary Outcomes

Assess product useability

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.

Time frame: Up to 7 nights/7 days

Secondary Outcomes

Collect ECG and accelerometer data; device wearability; and evaluate adverse events.

Assess ECG and accelerometer data, device adhesion and dermal response

Time frame: Up to 7 nights/7 days

Data from ClinicalTrials.gov

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