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

September 14, 2010
January 20, 2011
September 2010
October 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01202682 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Heart Rate Changes During Normal Activity, Exercise, and Sleep in Normal Healthy Subjects With and Without Epilepsy
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Normal, healthy population.

  • Healthy
  • Exercise
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01202682
E-34
No
Shaun Comfort, MD, Study Project Manager
Cyberonics, Inc.
Not Provided
Not Provided
Cyberonics, Inc.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP