Clinical trial NCT01202682: Heart Rate Changes During Normal Activity, Exercise, and Sleep in Normal Healthy Subjects With and Without Epilepsy
Official title: Heart Rate Changes During Normal Activity, Exercise, and Sleep in Normal Healthy Subjects With and Without Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Exercise
Keywords: Healthy subject exercise study
Lead sponsor: Cyberonics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal, healthy population.

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
Study officials:
References: