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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626599
• Other study ID #: PG-01
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: April 2014

Study information

• Verified date: July 2020
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	United States, Texas	Austin	Texas
United States	United States, North Carolina	Charlotte	North Carolina
United States	United States, Illinois	Chicago	Illinois
United States	United States, Texas	Houston	Texas
United States	United States, Texas	Houston	Texas
United States	United States, Texas	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 7 nights/7 days
Secondary	Collect ECG and accelerometer data; device wearability; and evaluate adverse events.	Assess ECG and accelerometer data, device adhesion and dermal response	Up to 7 nights/7 days