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

Cyberonics

Status: Completed

Conditions: Epilepsy

Treatments: Device: ProGuardian

Study type: Interventional

Funder types: Industry

Identifiers

NCT01626599

PG-01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 147 patients

Sex: All

Ages: 5+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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147 participants in 1 patient group

Assess product useability

Other group

Description:

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

Treatment:

Device: ProGuardian