I-Corps: A home-based kit for monitoring melatonin profile in insomnia patients

I-Corps项目更广泛的影响/商业潜力是开发一种设备，用于在家中测试患有昼夜节律睡眠障碍的个人。传统的测试，称为暗光褪黑激素发作（DLMO）测试，通常在实验室由训练有素的工作人员进行。提出的家用DLMO设备可以使生物医学研究人员了解无法参与研究的患者的昼夜节律和相关健康影响。此外，该技术可能允许对睡眠障碍进行高确定性的医学诊断，这可能会帮助约20%的患有昼夜节律障碍的睡眠失眠症患者接受适当的治疗，同时消除数月的反复试验睡眠治疗。该项目将把褪黑素昼夜节律研究人员和因其他疾病在家的个人或老年患者作为潜在客户。这个I-Corps项目的基础是开发一种不需要使用训练有素的工作人员的家庭昏暗褪黑激素起效（DLMO）测试设备。暗光褪黑素发作（DLMO）是诊断昼夜节律睡眠障碍的关键参数。目前，准确测量一个人DLMO的唯一方法是在睡眠设施中，由训练有素的工作人员在睡前6小时收集患者的唾液样本。这是一个昂贵的程序，使得不能在实验室里呆一整个晚上的人不可能测量他们的DLMO。所提出的设备是一种执行实验室技术人员任务的智能机器。它允许用户在家中进行唾液样本采集，同时监测用户是否成功地遵循了协议。此外，建议的设备使用性能最好的褪黑激素放射免疫测定（RIA），通过独立研究验证，设备报告样品收集时间，样品温度从收集的那一刻起，直到返回给研究人员，以及参与者是否按要求佩戴蓝色屏蔽眼镜。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the development of a device to test individuals with circadian rhythm sleep disorders at home. Conventional testing, called Dim Light Melatonin Onset (DLMO) testing, is typically conducted in a laboratory by trained staff. The proposed in-home DLMO device may enable biomedical researchers to understand the circadian rhythms and related health impacts of patients otherwise unable to participate in studies. In addition, the technology may allow for medical diagnosis of sleep disorders at high certainty, which may help the ~20% of sleep insomnia patients with circadian rhythm disorders to receive the proper treatment while eliminating months of trial-and-error sleep treatments. The project will target melatonin circadian rhythm researchers and individuals homebound due to other illness or senior patients as potential customers. This I-Corps project is based on the development of a device for home-based Dim Light Melatonin Onset (DLMO) testing that does not require the use of trained staff. Dim Light Melatonin Onset (DLMO) is a key parameter for the diagnosis of circadian rhythm sleep disorders. Currently, the only way to accurately measure a person’s DLMO is in a sleep facility with trained staff collecting saliva samples from a patient for 6 hours before bedtime. This is an expensive procedure and makes it impossible for individuals that cannot be in a lab for an entire evening to have their DLMO measured. The proposed device is an intelligent machine that performs the tasks of a lab technician. It allows the user to perform the saliva sample collection at home, while monitoring whether the user successfully follows the protocol. In addition, the proposed device uses the best performing melatonin radioimmunoassay (RIA), validated via independent research studies, and the device reports the sample collection times, sample temperatures from the moment collected until returned to the researcher, and whether the participant wore blue blocking glasses as required.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.