EAGER: The Sleep Environment as a Risk Factor for Eye Pressure Elevation

拟议的EAGER研究项目将获得所需的初步数据，以确定非仰卧睡眠期间与眼睛接触的物理环境与非仰卧睡眠期间持续升高的眼压（IOP）之间存在相关性。本研究要验证的假设是，传统的睡眠环境，即在传统的床垫和枕头上休息，将非仰卧睡眠者的眼睛置于导致IOP升高的物理环境中。为了验证这一假设，研究对象，一半是健康的眼睛，一半是不对称青光眼损伤，将安装两个Sensimed Triggerfish®无线隐形眼镜应变传感器（每只眼睛一个）。这些传感器将用于记录夜间眼内压的变化。这项研究将在约翰霍普金斯睡眠中心进行，同时记录睡眠姿势的视频。眼内压和位置数据将用于将眼睛接触与物理环境的眼内压变化联系起来，并确定患有和不患有青光眼的受试者对物理环境特性变化的敏感性的潜在差异。建立假设相关性的技术优点在于促进了对一个迄今为止被忽视的有助于IOP升高的因素的理解。意义在于IOP升高是青光眼患者眼损伤和视力丧失的主要危险因素。（青光眼是全球第二大致盲原因，目前影响全球约6000万人；预计到2020年，这一数字将增加到8000万）验证这一假设的影响是，了解睡眠环境是疾病进展的主要风险因素，将有助于制定修复或改变环境的策略。拟议研究的探索性，即需要资金来获得证实拟议假设的初步结果，是拟议研究不适合现有方案机会的原因。通过EAGER机制为这项研究寻求支持的理由是，拟议的研究具有高风险、探索性和潜在的变革性。这项研究是高风险的，因为传统观点认为结果将是负面的。近400年来，人们对这种疾病的不同方面进行了研究，为什么这种宏观层面的问题却被忽视了呢？视力专家很容易提供以下理由作为目前忽视来自睡眠环境的负荷作为青光眼患者的危险因素的做法的理由：术前对眼睛施加压缩负荷通常用于增加水流出，从而降低IOP。然而，这一论点忽略了负载应用过程中眼睛环境差异的潜在重要性；这些差异的重要性正是我们所提出的研究的目的。接下来，该研究是探索性的，因为这将是第一次定量研究非仰卧睡眠期间眼睛所暴露的环境与IOP的相互作用。2011年，Sensimed的Triggerfish®无线隐形眼镜应变传感器的出现极大地促进了获得初步结果以解决这项研究的能力。最后，如果/当研究假设被证明是正确的，该研究对青光眼相关视力障碍患者的广泛影响将是变革性的。传统观念完全忽视了睡眠环境是青光眼患者的一个风险因素，而这项研究对改变这种观念的影响将是立竿见影的。进一步研究如何最有效地改变睡眠环境以减轻IOP升高是必要的。拟议的EAGER研究结果将提供所需的初步结果，以提高人们对睡眠环境可能对非仰卧睡眠的青光眼患者造成重大风险的认识，并且改变睡眠环境可用于减缓这些患者所经历的视野逐渐丧失。

PI: Flatau, AlisonProposal Number: 1337502The proposed EAGER research project will lead to obtaining the preliminary data needed to establish that a correlation exists between the physical environment in contact with eyes during non-supine sleep and sustained periods of elevated intraocular pressure (IOP) during non-supine sleep. The hypothesis to be tested by this research is that a traditional sleep environment, i.e. resting on a conventional mattress and pillow, places the eyes of non-supine sleepers in a physical environment that leads to an elevation in IOP. To test this hypothesis, study subjects, half with healthy eyes and half with asymmetric glaucoma damage, will be fitted with two Sensimed Triggerfish® wireless, contact-lens-based strain sensors (one in each eye). These sensors will be used to record changes in IOP throughout the night. The studies will be conducted at the Johns Hopkins Sleep Center to simultaneously record video of sleep positions. IOP and position data will be used to correlate eye contact with the physical environment to changes in IOP as well as to establish potential differences in the sensitivity of subjects with and without glaucoma to variations in physical environment properties. The technical merit of establishing the hypothesized correlation lies in advancing the understanding of a here-to-fore overlooked factor that contributes to the elevation of IOP. The significance of is that IOP elevation is primary risk factor associated with eye damage and vision loss in individuals with glaucoma. (Glaucoma is the second leading cause of blindness worldwide and affects an estimated 60 million people globally at this time; a number is expected to increase to 80 million by 2020) The impact of validating this hypothesis is that understanding that the sleep environment contributes to the primary risk factor for disease progression will lead to developing strategies to fix or alter the environment. The exploratory nature of the proposed research, i.e. that funding is needed to obtain preliminary results that substantiate the proposed hypothesis, is the reason the proposed research does not fit well within the existing programmatic opportunities. The justification for seeking support for this research through the EAGER mechanism is that the proposed research is high risk, exploratory, and potentially transformative. The research is high risk in that conventional wisdom suggests that the result will be negative. After almost 400 years of study related to different aspects of this disease, how is it that this macro-scale concern has been neglected? Vision experts readily provide the following as the justification for the current practice of ignoring loads from the sleep environment as a risk factor for glaucoma patients: the pre-operative application of compressive loads to the eye is routinely used to increase aqueous outflow and thereby lower IOP. This argument, however, neglects the potential importance of differences in the eye environment during load application; the importance of these differences is precisely what we aim to discover with the proposed research. Next, the proposed research is exploratory in that this will be the first quantitative study of the interaction of environment to which the eye is exposed during non-supine sleep with IOP. The ability to obtain preliminary result to address this research is greatly facilitated by of the advent in 2011 of Sensimed's Triggerfish® wireless contact-lens-based strain sensors. Finally, if/when the research hypothesis is demonstrated to be correct, the broader impact of the research on those with glaucoma-related visual impairment will be transformational. The impact on altering conventional wisdom, which completely neglects sleep environment as a risk factor for those with glaucoma, will be immediate. Further research will be necessary to address how to most effectively alter sleep environments to mitigate IOP elevation. Results from the proposed EAGER research will provide the preliminary results needed to raise awareness of that sleep environment can pose a significant risk for glaucoma patients who are non-supine sleepers, and that modifications to a sleep environment can be used to slow the progressive loss to field of vision experienced by these individuals.