NCT01626599已完成不适用
Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 6
- 主要终点
- Assess product useability
研究概览
简要总结
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.
详细描述
This is a prospective, interventional, un-blinded, non-significant risk, multi-site study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Assess product useability
Other
All subjects participate in the same arm. This arm completes the primary objective of product usability.
干预措施: ProGuardian (Device)
结局指标
主要结局
Assess product useability
时间窗: 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.
次要结局
- Collect ECG and accelerometer data; device wearability; and evaluate adverse events.(Up to 7 nights/7 days)
研究者
研究点 (6)
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