A sleep biomarker test for management of ADHD

项目摘要 PGXL Technologies正在开发用于阻塞性睡眠呼吸暂停快速筛查的Uromarker测试 (OSA)和睡眠呼吸障碍，可能导致注意力缺陷多动障碍（ADHD）， 孩子ADHD是儿童中最常见的行为障碍，对儿童的短期和长期行为有显著影响。 长期结果，包括教育表现不佳，药物滥用的风险增加， 职业成功，除此之外。最近的研究表明，多达70%的患者 ADHD有轻度到重度的睡眠问题。OSA和睡眠障碍患者的日间行为症状 呼吸与ADHD的临床表现有许多相似之处，包括注意力调节受损， 过度活跃、情绪不稳定、行为问题、冲动控制不良和反应时间延长。协会 睡眠问题和多动症之间的关系可能是复杂和多方面的，但越来越多的证据表明， 表明OSA的治疗可以减少甚至消除ADHD症状。 采用标准方法（如扁桃体切除术）治疗OSA， 治疗后一年内ADHD症状减少。OSA患者的识别 因此，ADHD将有助于确定多模式治疗方法中更合适的第一步 ADHD不幸的是，儿童阻塞性睡眠呼吸暂停综合征和睡眠障碍只能通过多导睡眠图检查来诊断 这是昂贵的，需要通宵睡眠研究，并往往有很长的等待时间，病人接受 test.这些测试在ADHD检查中并不被常规考虑。快速筛查法的建立 阻塞性睡眠呼吸暂停和睡眠呼吸障碍将提供重要的临床价值，在诊断ADHD的澄清。 为了满足这一需求，PGXL技术正在开发Uromarker测试，一种快速的多重测试， 使用尿液中存在的4种生物标志物，有效且经济地识别OSA或睡眠呼吸障碍 小儿这些生物标志物，当组合使用时，先前已显示具有100%的灵敏度 与健康的原发性打鼾对照相比，儿童OSA检测的特异性为96.5%。PGXL 技术拥有这些生物标志物的专利，在第一阶段的提案中，PGXL将开发这些生物标志物。 使用所有4种生物标志物进行多路复用、高通量测定，并将分析表征 比色法还将证明尿液中生物标志物的稳定性，以显示邮寄尿液的可行性 收集套件，将能够识别OSA和睡眠呼吸障碍的儿童，以支持 ADHD诊断

PROJECT SUMMARY PGXL Technologies is developing the Uromarker test for rapid screening of obstructive sleep apnea (OSA) and sleep disordered breathing that may contribute to attention deficit hyperactivity disorder (ADHD) in children. ADHD is the most common behavioral disorder in children and has significant effects on short- and long-term outcomes including poor education performance, increased risk of substance abuse, and reduced occupational success, amongst others. Recent research has identified that as many as 70% of patients with ADHD have mild to severe sleep problems. Daytime behavioral symptoms seen in OSA and sleep disordered breathing share many similarities with the clinical manifestations of ADHD including impaired attention regulation, overactivity, mood lability, behavior problems, poor impulse control, and prolonged reaction time. The association between sleep problems and ADHD are likely complex and multidirectional, but there is increasing evidence that demonstrates treatment of OSA may decrease or even eliminate ADHD symptoms. Treatment of OSA with standard approaches such as adenotonsillectomy has been associated with decreased ADHD symptoms up to a year after treatment. Identification of patients with OSA in the context of ADHD will therefore aid in determining the more appropriate first step in the multi-modal approach to treatment of ADHD. Unfortunately, OSA and sleep disturbances in children are only diagnosed with polysomnography tests that are expensive, require overnight sleep studies, and often have long wait times for patients to receive the test. These tests are not routinely considered in ADHD work-up. The development of a rapid screening test for OSA and sleep disordered breathing will provide significant clinical value in the diagnostic clarification of ADHD. To address this need, PGXL Technologies is developing the Uromarker test, a rapid multiplexed test that uses 4 biomarkers present in urine to efficiently and cost-effectively identify OSA or sleep disordered breathing in children. These biomarkers, when used in combination, have previously been shown to have 100% sensitivity and 96.5% specificity for detection of OSA in children compared to healthy primary snoring controls. PGXL Technologies has the patent to these biomarkers and, in this Phase I proposal, PGXL will develop these biomarkers into a multiplexed, high-throughput assay using all 4 biomarkers and will analytically characterize the assay. The stability of the biomarkers in urine will also be demonstrated to show feasibility for a mail-in urine collection kit that will enable identification of OSA and sleep disordered breathing in children towards supporting ADHD diagnosis.