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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Exercise

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal, healthy population.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Cyberonics, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: September 14, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Estimate): January 24, 2011
• Last Update Submitted That Met QC Criteria: January 20, 2011
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Healthy subject exercise study
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: E-34