Heart Rate Changes During Normal Activity, Exercise, and... | NCT01202682

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

NCT01202682

Sponsor

Cyberonics, Inc.

Status

Completed

Last Update Posted

Jan 24, 2011Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Healthy
Exercise

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Sep 14, 2010

First Submission Date that Met QC Criteria

Sep 15, 2010

First Posted Date

Sep 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2011

Last Update Posted Date

Jan 24, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must be 18 years or older and may be of either sex and of any race.
Subject must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements.
Subject must be willing and able to complete informed consent and HIPAA authorization.
Subject may be diagnosed with epilepsy but must be well controlled on their regular treatment regimen.
Women of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria:

Subjects with skin abnormalities or conditions that would interfere with ECG electrode patch placement or cause subject discomfort with patch placement.
Subjects report history of allergies or sensitivity to adhesive tapes or patches.
Subjects with severe psychiatric disease that in the investigator's judgment would prevent the subject's successful completion of the study.
Subjects with epilepsy experiencing status epilepticus within the last 6 months.
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.
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.
Use of beta adrenergic antagonists (i.e., "beta blockers") or calcium channel blocker agents that may affect heart rate.
Subjects currently dependent on alcohol or narcotic drugs as defined by DSM IV-TR.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Normal, healthy population.

Sampling Method

Non-Probability Sample