Heart Rate Changes During Normal Activity, Exercise, and Sleep in Normal Healthy Subjects With and Without Epilepsy

NCT ID: NCT01202682

Last Updated: 2011-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-10-31

Brief Summary

The purpose of this study is to gather ECG data during normal activity, exercise, and sleep from normal subjects with or without well-controlled epilepsy. This normal subject data will serve as "true negative" (i.e., no seizure occurring) challenge data for testing cardiac based seizure detection algorithms.

Detailed Description

The purpose of this study is to gather ECG data during normal activity, exercise, and sleep from normal subjects with or without well-controlled epilepsy. This normal subject data will serve as "true negative" (i.e., no seizure occurring) challenge data for testing cardiac based seizure detection algorithms.

Conditions

Healthy; Exercise

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Subjects must be 18 years or older and may be of either sex and of any race.

2. Subject must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements.

3. Subject must be willing and able to complete informed consent and HIPAA authorization.

4. Subject may be diagnosed with epilepsy but must be well controlled on their regular treatment regimen.

5. Women of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria

1. Subjects with skin abnormalities or conditions that would interfere with ECG electrode patch placement or cause subject discomfort with patch placement.

2. Subjects report history of allergies or sensitivity to adhesive tapes or patches.

3. Subjects with severe psychiatric disease that in the investigator's judgment would prevent the subject's successful completion of the study.

4. Subjects with epilepsy experiencing status epilepticus within the last 6 months.

5. Subjects with cardiovascular, respiratory, neuromuscular or gait disorders that in the investigator's judgment would cause unnecessary risk or inability to participate in the protocol.

6. Subjects with known cardiovascular arrhythmias or cardiac disease resulting in history of cardiac disease or abnormal ECG recordings. These include, but are not limited to, conditions such as chronic atrial fibrillation and permanent cardiac pacemaker implantation.

7. Use of beta adrenergic antagonists (i.e., "beta blockers") or calcium channel blocker agents that may affect heart rate.

8. Subjects currently dependent on alcohol or narcotic drugs as defined by DSM IV-TR.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cyberonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Study Project Manager

Locations

Clinical Trials of Texas

San Antonio, Texas, United States

Countries

United States

Other Identifiers

E-34

Identifier Type: -

Identifier Source: org_study_id