NCT01626599

Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data

Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Cyberonics, Inc. · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to collect data to support development of a novel product designed to sense changes in heart rate or movement during periods of sleep in people with epilepsy. When a potential seizure is detected, the system sends out an audio-visual notification.

Detailed description

This is a prospective, interventional, un-blinded, non-significant risk, multi-site study.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	ProGuardian	The investigational system is composed of a sensor, patch, hub, and caregiver application. The sensor is applied externally during periods of nocturnal sleep for up to 7 nights. The investigational system: * is not implantable and no surgical procedure is required for a human subject to use the devices; * is not for use in supporting or sustaining a human life; and * is not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health. * Contains skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles.

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-06-25
• Last updated: 2020-08-05

Locations

6 sites across 1 country: United States