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

This study has been completed.
Sponsor:
Information provided by:
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01202682
First received: September 14, 2010
Last updated: January 20, 2011
Last verified: September 2010
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202682

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

No publications provided

Responsible Party: Shaun Comfort, MD, Study Project Manager
ClinicalTrials.gov Identifier: NCT01202682     History of Changes
Other Study ID Numbers: E-34
Study First Received: September 14, 2010
Last Updated: January 20, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014