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

RestEaze：一种新型可穿戴设备和移动应用程序，可改善注意力缺陷/多动症儿科患者不宁腿综合症的诊断和管理

• 批准号: 10760442
• 负责人: CODY GREGORY FELTCH
• 金额: $ 48.66万
• 依托单位: TANZEN MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10760442
• 关键词: Academic achievement; Academy; Address; Algorithms; American; Ankle; Attention deficit hyperactivity disorder; Biological Markers; Breakthrough device; Caregiver Burden; Caregivers; Child; Childhood; Clinical; Clinical Trials; Communication; Data; Devices; Diagnosis; Economic Burden; Economics; Emotional; Ensure; Expenditure; Family; Feeling; Financial Hardship; Funding; Future; General Population; Generations; Goals; Health; Hyperactivity; Impulsivity; Incidence; Individual; Industrialization; Iron; Laboratories; Leg; Longitudinal Studies; Marketing; Measurement; Measures; Medical; Medicine; Mental disorders; Methods; Movement; Occupational; Oral; Pain; Participant; Patients; Pediatrics; Performance at work; Periodicals; Phase; Polysomnography; Population; Prevalence; Quality of life; Reporting; Restless Legs Syndrome; Schedule; Sleep; Sleep Disorders; Sleep disturbances; Small Business Innovation Research Grant; Symptoms; System; Technology; Testing; United States Food and Drug Administration; accurate diagnosis; affective disturbance; comorbidity; design; diagnostic value; improved; improved outcome; inattention; indexing; iron supplementation; mobile application; novel; pediatric patients; poor sleep; sensor; usability; verbal; wearable device

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.

项目摘要 数百万患有注意力缺陷/多动症 (ADHD) 的儿科患者患有睡眠障碍 这大大降低了他们的生活质量，并加重了他们沉重的情感和经济负担 不宁腿综合症（RLS）是这些人睡眠障碍的一个可能（且可治疗）因素。 口服铁疗法已被证明可以改善儿童的睡眠和多动症症状。 RLS 目前很难诊断，尤其是患有 ADHD 的儿科患者。诊断是通过临床进行的。 由于主观原因，患者的报告和症状本身在个体之间存在差异。 可能已经有语言表达困难的多动症患者特别容易被误诊。 RestEaze 是 Tanzen Medical Inc. 开发的一款踝戴式可穿戴技术和移动应用程序，旨在 测量睡眠期间与 RLS 高度相关的腿部运动，可以作为 RLS 的客观生物标志物 该设备经过工业设计，可让患者佩戴舒适，并且可清洗。 该移动应用程序易于患者（或护理人员）在夜间使用，以便与患者进行互动和交流。 存储来自设备的数据，提供给临床医生的读数提供了清晰、可操作的信息： 参考美国睡眠医学会量化患者睡眠期间的腿部运动 总之，RestEaze 通过提供技术直接解决重大的未满足的医疗需求。 可以显着改善儿童 RLS 患者的诊断和后续治疗 ADHD 的使用有望改善 ADHD 患者及其生活质量。 护理人员通过直接解决他们的睡眠障碍。