RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Legs Syndrome in Pediatric Patients with Attention Deficit/Hyperactivity Disorder

项目摘要 数百万患有注意力缺陷/多动症（ADHD）的儿童患者患有睡眠障碍 这大大降低了他们的生活质量，并放大了沉重的情感和经济负担， 照顾者不宁腿综合征（RLS）是一个可能的（和可治疗的）因素的睡眠障碍，在这些 患者口服铁治疗已被证明可以改善儿童的睡眠和ADHD症状。然而，在这方面， RLS目前很难诊断，特别是在患有ADHD的儿科患者中。诊断是临床上作出的 由于主观性，患者报告和症状本身在个体之间是可变的。因此，患者 ADHD患者可能已经有语言表达困难，特别容易被误诊。 RestEaze是由Tanzen Medical Inc.开发的踝关节穿戴式技术和移动的应用程序。到 测量睡眠期间与RLS高度相关的腿部运动，并可作为 病情该器械在工业上设计为患者佩戴舒适，可清洗， 夜间使用。所述移动的应用易于由患者（或护理者）使用以与所述设备交互， 存储来自设备的数据。提供给临床医生的读数提供了清晰的、可操作的信息， 根据美国睡眠医学学会的研究， 标准总之，RestEaze通过提供一种技术， 这可以大大提高RLS的诊断和随后的管理，在儿科患者， 多动症。这项技术的使用有望改善ADHD患者的生活质量， 直接解决他们的睡眠障碍。

Project Abstract Millions of pediatric patients with attention-deficit/hyperactivity disorder (ADHD) suffer from sleep disturbances that significantly degrade their quality of life and amplifies the heavy emotional and financial burden on caregivers. Restless Legs Syndrome (RLS) is a likely (and treatable) factor for the sleep disturbance in these patients. Oral iron therapy has been shown to improve both sleep and ADHD symptoms in children. However, RLS is currently difficult to diagnose, particularly in pediatric patients with ADHD. The diagnosis is made clinically with subjective, patient reports and the symptoms themselves are variable across individuals. Thus, patients with ADHD who may already have difficulty with verbal expression are especially vulnerable to being misdiagnosed. RestEaze is an ankle-worn wearable technology and mobile application developed by Tanzen Medical Inc. to measure leg movements during sleep that are highly related to RLS and can serve as an objective biomarker of the condition. The device is industrially designed to be comfortably worn by the patient and washable to permit extended, nightly use. The mobile application is easy to use by the patient (or caregiver) to interact with and store data from the device. The read-out provided to the clinician provides clear, actionable information that quantifies the patients’ leg movements during sleep in reference to American Academy of Sleep Medicine standards. In sum, RestEaze directly addresses a significant unmet medical need by providing a technology that can substantially improve the diagnosis and subsequent management of RLS in pediatric patients with ADHD. The use of this technology is expected to improve the quality of life for patients with ADHD and their caregivers by directly addressing their sleep disturbance.