Clinical trial NCT01626599: Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data
Official title: Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: ECG
Accelerometer
Device
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 147
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria:

1. Five (5) years of age or older
2. 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.
3. 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.
4. A self-reported diagnosis of epilepsy.
5. Currently taking at least one antiepileptic medication.

Caregivers must meet the following inclusion criteria:

1. Eighteen (18) years of age or older
2. 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
3. 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:

1. Any visible skin disorder, condition, or abnormal skin pigmentation which, in the investigators opinion, would interfere with the ability to wear the patch.
2. 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.
3. Known sensitivity or history of irritation to adhesive tape (Latex) and/or topically applied products
4. An implanted defibrillator and/or pacemakers
5. Severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
6. Pregnant and or nursing women (verified by a urine pregnancy test).
7. Currently participating in another clinical study without sponsor approval.
8. Caregiver that is unable to read instructions in the English language.

Exclusion Criteria for Caregiver:

1. Under 18 years of age
2. 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

Primary outcomes:
measure: Assess product useability
timeFrame: Up to 7 nights/7 days
Secondary outcomes:
measure: Collect ECG and accelerometer data; device wearability; and evaluate adverse events.
timeFrame: Up to 7 nights/7 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: United States, Illinois
state: Illinois
city: Charlotte
country: United States
facility: United States, North Carolina
state: North Carolina
city: Austin
country: United States
facility: United States, Texas
state: Texas
city: Houston
country: United States
facility: United States, Texas
state: Texas
city: Houston
country: United States
facility: United States, Texas
state: Texas
city: San Antonio
country: United States
facility: United States, Texas
state: Texas
Study officials:
affiliation: Cyberonics, Inc.
name: Jason Begnaud
role: STUDY_DIRECTOR
References: