Byteflies Real-world Data Study: Assessing the Clinical Utility of Reduced EEG Montage Home Monitoring for Clinician-driven Fenfluramine Titration in Dravet Syndrome and Lennox-Gastaut Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Byteflies
- 入组人数
- 20
- 主要终点
- Physician confidence in treatment decision-making using RPM data
研究概览
简要总结
The goal of this real world data study is to evaluate the clinical utility of remote patient monitoring solution (using Byteflies' EpiCare@Home with reduced EEG montage and other vital signs) with Dravet and LGS patients (ages 3 and up with the exclusion of adults above weight allowing variable titration) to identify an optimal Fenfluramine treatment.
Patients will wear one or more small portable and medically certified measuring devices. Through these devices, electroencephalography (EEG) signals, as well as electro-cardiography (ECG), heart rate, respiration rate, and physical activity are measured, which allows the patient's physician to detect potential seizures, and thus gain more insights.
Participants will be asked to wear the devices three times at home for remote monitoring periods lasting between 3 and 7 consecutive days. The duration of each monitoring period will be determined by the physician based on the type of epilepsy and the frequency of seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed Dravet syndrome or Lennox-Gastaut syndrome diagnosis who are eligible for Fenfluramine.
- •Patients for which the neurologist decided to prescribe Fenfluramine as a relevant treatment approach and who have not been prescribed Fenfluramine before.
- •Patients or caregivers should be able and willing to maintain a seizure diary e.g. using a digital seizure diary.
排除标准
- •Patients who
- •Have been diagnosed with or are suspected to have life-threatening conditions that could result in immediate danger;
- •Need to undergo an MRI scan or cardiac defibrillation;
- •Have an active implanted device such as a pacemaker, defibrillator, or vagal nerve, or brain stimulator;
- •Are unable to provide written informed consent, either directly or via a legal guardian.
- •Have known allergy or skin-sensitivity to the materials used in the Byteflies Adhesives
- •Are between 0 and 3 years of age;
- •Are above weight allowing variable titration
- •The patient is on any medication that would be contra-indicated for use with Fenfluramine at the execution of the study eg. LP352 (bexicaserin), loracaserin, monoamine-oxidase inhibitors, SSRIs, SNRIs, tricyclic antidepressants or other serotonergic agonists or antagonists (antipsychotics).
- •Have a prescribed concomitant use of Stiripentol
- •Have any other condition or finding that would compromise the safety of the participant or the quality of the data, or otherwise interfere with achieving the objectives.
- •A history of cardiovascular or cerebrovascular disease, aortic or mitral valve regurgitation diagnosed by echography
- •Patients/caregivers who have only reported/detected non-motor seizures
结局指标
主要结局
Physician confidence in treatment decision-making using RPM data
时间窗: At end of first RPM period (2 weeks after treatment start), at end of second RPM period (between 1 to 3 months after treatment start), at end of third RPM period (between 3 to 9 months after treatment start)
The primary endpoint of the study is defined as the proportion of cases in which physicians report higher confidence in treatment decision-making when using RPM-enhanced data compared to standard care, with increased confidence defined as an RPM confidence score greater than the standard confidence score. The primary endpoint is considered successful if physicians demonstrate improved confidence in their treatment decisions for at least 50% of the patients when RPM data is available. For each patient, the following assessments will be performed: 1. Standard Decision (-RPM): Clinicians will determine the treatment plan based on routine data. Clinicians will record their confidence in this decision on a 1-5 Likert scale (1 = not confident, 5 = very confident). 2. RPM-Enhanced Decision (+RPM): Clinicians will determine the treatment plan using the same routine data plus information provided by the RPM system. Clinicians will record their confidence in this decision on a 1-5 Likert scale.
次要结局
未报告次要终点