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
1 other identifier
interventional
147
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 15, 2012
CompletedFirst Posted
Study publicly available on registry
June 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedAugust 5, 2020
July 1, 2020
1.8 years
June 15, 2012
July 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess product useability
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.
Up to 7 nights/7 days
Secondary Outcomes (1)
Collect ECG and accelerometer data; device wearability; and evaluate adverse events.
Up to 7 nights/7 days
Study Arms (1)
Assess product useability
OTHERAll subjects participate in the same arm. This arm completes the primary objective of product usability.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cyberonics, Inc.lead
Study Sites (6)
United States, Illinois
Chicago, Illinois, 60654, United States
United States, North Carolina
Charlotte, North Carolina, 28209, United States
United States, Texas
Austin, Texas, 78731, United States
United States, Texas
Houston, Texas, 77034, United States
United States, Texas
Houston, Texas, 77054, United States
United States, Texas
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jason Begnaud
Cyberonics, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2012
First Posted
June 25, 2012
Study Start
June 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
August 5, 2020
Record last verified: 2020-07