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This is a prospective, unblinded sub-study to the E-30 to gather physiological data.
This sub-study to the E-30 is designed to collect vital signs, accelerometer and ECG data on subjects, and will consist of two phases. Phase 1 is designed to collect data in an Epilepsy Monitoring Unit (EMU) and Phase 2 is designed to collect data in an everyday (ambulatory) setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiologic Data Collection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerometer Device | Device | A sensor platform that enables physiological monitoring in routine, home or office environments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gather physiological data | The purpose of this sub-study is to gather physiological data in consenting subjects who were previously enrolled in the "parent" E-30 study (NCT01202669). | Up to 2 weeks |
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Inclusion Criteria:
(Phase 1)
(Phase 1&2)
(Sleep State: Optional)
Exclusion Criteria:
(Phase 1&2)
(Sleep State: Optional)
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| Name | Affiliation | Role |
|---|---|---|
| Bryan Olin | Cyberonics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gainesville | Florida | 32610 | United States | |||
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Chicago |
| Illinois |
| 60637 |
| United States |