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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01202682
First Posted: September 16, 2010
Last Update Posted: January 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cyberonics, Inc.
  Purpose
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.

Condition
Healthy Exercise

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Heart Rate Changes During Normal Activity, Exercise, and Sleep in Normal Healthy Subjects With and Without Epilepsy

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Estimated Enrollment: 50
Study Start Date: September 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal, healthy population.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202682


Locations
United States, Texas
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Cyberonics, Inc.
  More Information

Responsible Party: Shaun Comfort, MD, Study Project Manager
ClinicalTrials.gov Identifier: NCT01202682     History of Changes
Other Study ID Numbers: E-34
First Submitted: September 14, 2010
First Posted: September 16, 2010
Last Update Posted: January 24, 2011
Last Verified: September 2010

Keywords provided by Cyberonics, Inc.:
Healthy subject exercise study

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases