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

Completed · Not applicable

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT01626599

Run by

Cyberonics, Inc.

People needed

147

Starts

2012-06-01

Expected to finish

2014-04-01

Last updated by the study team

2020-08-05

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• United States, Illinois — Chicago, Illinois, United States
• United States, North Carolina — Charlotte, North Carolina, United States
• United States, Texas — Austin, Texas, United States
• United States, Texas — Houston, Texas, United States
• United States, Texas — Houston, Texas, United States
• United States, Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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