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OpenTrials
Completed

NCT Number: NCT01626599

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United States, Illinois, Chicago, Illinois, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet all of the following inclusion criteria:

  • Five (5) years of age or older
  • Caregiver capable of understanding and willing to comply with instructions provided in English for proper use of the study device as well as scheduled study visits.
  • Guardian/Parent for subjects less than 18 years or with cognitive limitation that would preclude consent must be willing and able to complete informed consent/and HIPAA authorization.
  • A self-reported diagnosis of epilepsy.
  • Currently taking at least one antiepileptic medication.

Caregivers must meet the following inclusion criteria:

  • Eighteen (18) years of age or older
  • Capable of understanding and willing to comply with instructions provided in english for proper use of the study device as well as scheduled study visits
  • Willing and able to complete informed consent and HIPAA authorization.

Exclusion criteria

Subjects are not eligible to be enrolled in the study if they meet any of the following exclusion criteria:

  • Any visible skin disorder, condition, or abnormal skin pigmentation which, in the investigators opinion, would interfere with the ability to wear the patch.
  • History of chronic dermatological, medical, or physical conditions that would, in the investigators opinion, preclude topical application of the test products and/or influence the outcome of the test.
  • Known sensitivity or history of irritation to adhesive tape (Latex) and/or topically applied products
  • An implanted defibrillator and/or pacemakers
  • Severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
  • Pregnant and or nursing women (verified by a urine pregnancy test).
  • Currently participating in another clinical study without sponsor approval.
  • Caregiver that is unable to read instructions in the English language.

Exclusion criteria

for Caregiver:

  • Under 18 years of age
  • Not capable of understanding and willing to comply with instructions provided in English for proper use of the study device as well as scheduled study visits

Treatment and study plan

ProGuardian

Device

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.

Primary outcomes

  1. Assess product useability

    Time frame: Up to 7 nights/7 days

    This study is designed to collect usability data from the intended use population of people with epilepsy and their caregivers to support development of a novel product designed to capture ECG signals and accelerometer data.

Secondary outcomes

  1. Collect ECG and accelerometer data; device wearability; and evaluate adverse events.

    Time frame: Up to 7 nights/7 days

    Assess ECG and accelerometer data, device adhesion and dermal response

Sponsors and collaborators

Lead sponsor

Cyberonics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2012
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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