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

这个I-Corps项目更广泛的影响/商业潜力是开发一种设备，用于测试家中昼夜节律睡眠障碍的个人。 传统的测试，称为昏暗光褪黑激素发作（DLMO）测试，通常是在实验室进行的训练有素的工作人员。拟议的家庭DLMO设备可以使生物医学研究人员了解昼夜节律和相关的健康影响的患者，否则无法参与研究。此外，该技术还可以高确定性地对睡眠障碍进行医学诊断，这可能有助于约20%的昼夜节律紊乱的睡眠失眠患者接受适当的治疗，同时消除数月的试错睡眠治疗。该项目将针对褪黑激素昼夜节律研究人员和因其他疾病而在家的个人或老年患者作为潜在客户。这个I-Corps项目是基于开发一种用于家庭昏暗光褪黑激素发作（DLMO）测试的设备，该设备不需要使用经过培训的工作人员。 暗光褪黑激素起始（DLMO）是诊断昼夜节律睡眠障碍的关键参数。目前，准确测量一个人的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，并使它不可能为个人，不能在实验室的整个晚上有他们的DLMO测量。所提出的设备是一种智能机器，可以执行实验室技术人员的任务。 它允许用户在家中进行唾液样本收集，同时监测用户是否成功遵循协议。此外，所提出的设备使用通过独立研究验证的性能最好的褪黑激素放射免疫测定法（RIA），并且该设备报告样本收集时间、从收集到返回给研究人员的时刻的样本温度，该奖项反映了NSF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。

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.