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

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ProGuardian
Sponsored by
Cyberonics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epilepsy focused on measuring ECG, Accelerometer, Device

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • United States, Illinois
  • United States, North Carolina
  • United States, Texas
  • United States, Texas
  • United States, Texas
  • United States, Texas

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Assess product useability

Arm Description

All subjects participate in the same arm. This arm completes the primary objective of product usability.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Collect ECG and accelerometer data; device wearability; and evaluate adverse events.
Assess ECG and accelerometer data, device adhesion and dermal response

Full Information

First Posted
June 15, 2012
Last Updated
July 31, 2020
Sponsor
Cyberonics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01626599
Brief Title
Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data
Official Title
Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyberonics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
ECG, Accelerometer, Device

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assess product useability
Arm Type
Other
Arm Description
All subjects participate in the same arm. This arm completes the primary objective of product usability.
Intervention Type
Device
Intervention Name(s)
ProGuardian
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess product useability
Description
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 Outcome Measure Information:
Title
Collect ECG and accelerometer data; device wearability; and evaluate adverse events.
Description
Assess ECG and accelerometer data, device adhesion and dermal response
Time Frame
Up to 7 nights/7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Begnaud
Organizational Affiliation
Cyberonics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
United States, Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
United States, North Carolina
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
United States, Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
United States, Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
United States, Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
United States, Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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