Heart Rate Changes During Normal Activity, Exercise, and Sleep in Normal Healthy Subjects With and Without Epilepsy
This study has been completed.
Sponsor:
Cyberonics, Inc.
Information provided by:
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01202682
First received: September 14, 2010
Last updated: January 20, 2011
Last verified: September 2010
| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 14, 2010 |
| Last Updated Date | January 20, 2011 |
| Start Date ICMJE | September 2010 |
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01202682 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Heart Rate Changes During Normal Activity, Exercise, and Sleep in Normal Healthy Subjects With and Without Epilepsy |
| Official Title ICMJE | Heart Rate Changes During Normal Activity, Exercise, and Sleep in Normal Healthy Subjects With and Without Epilepsy |
| 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. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | Normal, healthy population. |
| Condition ICMJE |
|
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 50 |
| Completion Date | October 2010 |
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01202682 |
| Other Study ID Numbers ICMJE | E-34 |
| Has Data Monitoring Committee | No |
| Responsible Party | Shaun Comfort, MD, Study Project Manager |
| Study Sponsor ICMJE | Cyberonics, Inc. |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Cyberonics, Inc. |
| Verification Date | September 2010 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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