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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Cyberonics, Inc.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01626599
First received: June 15, 2012
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Epilepsy
Device: Cyberonics Investigational System

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • Assess product useability [ Time Frame: Up to 7 nights/7 days ] [ Designated as safety issue: No ]
    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:
  • Collect ECG and accelerometer data; device wearability; and evaluate adverse events. [ Time Frame: Up to 7 nights/7 days ] [ Designated as safety issue: No ]
    Assess ECG and accelerometer data, device adhesion and dermal response


Estimated Enrollment: 160
Study Start Date: June 2012
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Cyberonics Investigational System

    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. This investigational system is non-significant risk (NSR) because it does not present a potential for serious risk to health, safety or welfare of a human subject, specifically the 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.
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of adults and children with epilepsy and their caregivers.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626599

Contacts
Contact: Jeff Way, Clinical Study Manager (800) 332-1375 ext 7394 Jeffrey.way@cyberonics.com

Locations
United States, Illinois
United States, Illinois Recruiting
Chicago, Illinois, United States, 60654
United States, North Carolina
United States, North Carolina Recruiting
Charlotte, North Carolina, United States, 28209
United States, Texas
United States, Texas Recruiting
Austin, Texas, United States, 78731
United States, Texas Completed
Houston, Texas, United States, 77034
United States, Texas Completed
Houston, Texas, United States, 77054
United States, Texas Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
Study Director: Ed Thomas Cyberonics, Inc.
  More Information

No publications provided

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01626599     History of Changes
Other Study ID Numbers: PG-01
Study First Received: June 15, 2012
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cyberonics, Inc.:
ECG
Accelerometer
Device

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 01, 2014