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

• Sponsor: Cyberonics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01626599
• Collaborator: (none)
• Enrollment: 147
• Locations: 6
• Arm: 1
• Duration (Months): 22
• Patients Per Site: 24.5
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Device: ProGuardian	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 147 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

1. Assess product useability [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

1. Collect ECG and accelerometer data; device wearability; and evaluate adverse events. [Up to 7 nights/7 days]

   Assess ECG and accelerometer data, device adhesion and dermal response

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	United States, Illinois	Chicago	Illinois	United States	60654
2	United States, North Carolina	Charlotte	North Carolina	United States	28209
3	United States, Texas	Austin	Texas	United States	78731
4	United States, Texas	Houston	Texas	United States	77034
5	United States, Texas	Houston	Texas	United States	77054
6	United States, Texas	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Cyberonics, Inc.

Investigators

• Study Director: Jason Begnaud, Cyberonics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cyberonics, Inc.
• ClinicalTrials.gov Identifier: NCT01626599
• Other Study ID Numbers: PG-01
• First Posted: Jun 25, 2012
• Last Update Posted: Aug 5, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Cyberonics, Inc.: ECG; Accelerometer; Device
• Additional relevant MeSH terms: Epilepsy

Study Results

No Results Posted as of Aug 5, 2020