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

This study has been completed.
Information provided by (Responsible Party):
Cyberonics, Inc. Identifier:
First received: June 15, 2012
Last updated: September 17, 2015
Last verified: September 2015
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
Device: ProGuardian

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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 ]
    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 ]
    Assess ECG and accelerometer data, device adhesion and dermal response

Enrollment: 147
Study Start Date: June 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Assess product useability
All subjects participate in the same arm. This arm completes the primary objective of product usability.
Device: ProGuardian

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.

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

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01626599

United States, Illinois
United States, Illinois
Chicago, Illinois, United States, 60654
United States, North Carolina
United States, North Carolina
Charlotte, North Carolina, United States, 28209
United States, Texas
United States, Texas
Austin, Texas, United States, 78731
United States, Texas
Houston, Texas, United States, 77034
United States, Texas
Houston, Texas, United States, 77054
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Cyberonics, Inc.
Study Director: Jason Begnaud Cyberonics, Inc.
  More Information

Responsible Party: Cyberonics, Inc. Identifier: NCT01626599     History of Changes
Other Study ID Numbers: PG-01
Study First Received: June 15, 2012
Last Updated: September 17, 2015

Keywords provided by Cyberonics, Inc.:
Device processed this record on May 23, 2017