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

PI：Flatau，Alison Proposal编号：1337502拟议的急切研究项目将导致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的眼压升高之间存在相关性。这项研究要检验的假设是，传统的睡眠环境，即躺在传统的床垫和枕头上，会将非仰卧睡眠者的眼睛置于导致眼压升高的物理环境中。为了验证这一假设，研究对象，一半是健康的眼睛，另一半是非对称性青光眼受损的人，将安装两个Sensimed TriggerFish®无线、基于隐形眼镜的应变传感器(每只眼睛一个)。这些传感器将被用来记录整个晚上眼压的变化。这项研究将在约翰·霍普金斯睡眠中心同时录制睡眠姿势的视频。眼压和位置数据将被用来将眼睛与物理环境的接触与眼压的变化联系起来，并建立患有青光眼和不患有青光眼的受试者对物理环境特性变化的敏感度的潜在差异。建立这种假设相关性的技术优势在于促进了人们对导致眼压升高的一个被忽视的因素的理解。其意义在于，在青光眼患者中，眼压升高是与眼睛损伤和视力丧失相关的主要危险因素。(青光眼是全球第二大致盲原因，目前全球估计有6000万人受到影响；预计到2020年，这一数字将增加到8000万。)证实这一假设的影响是，了解睡眠环境是疾病进展的主要风险因素，将导致制定修复或改变环境的战略。拟议研究的探索性性质，即需要资金才能获得证实拟议假设的初步结果，是拟议研究不能很好地符合现有方案机会的原因。通过急切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。这项研究的风险很高，因为传统观点认为，结果将是负面的。在近400年来对这种疾病的不同方面进行了研究后，这一宏观层面的关切怎么会被忽视呢？视力专家很容易为目前忽视睡眠环境负荷作为青光眼患者风险因素的做法提供以下理由：术前对眼睛施加压力负荷通常用于增加房水流出，从而降低眼压。然而，这一论点忽略了负重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希望通过拟议的研究发现的。其次，这项拟议的研究是探索性的，因为这将是第一次定量研究眼睛在非仰卧睡眠期间接触到的环境与眼压的相互作用。2011年，Sensimed基于TriggerFish®无线隐形眼镜的应变传感器问世，极大地促进了获得解决这一研究的初步结果的能力。最后，如果研究假设被证明是正确的，这项研究对青光眼相关视力障碍患者的更广泛影响将是变革性的。这对改变传统观念的影响将是立竿见影的，传统观念完全忽视了睡眠环境是青光眼患者的风险因素。需要进一步的研究来解决如何最有效地改变睡眠环境以减轻眼压升高的问题。来自拟议的急切研究的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构成重大风险的认识，以及对睡眠环境的修改可以用来减缓这些人经历的进行性视野丧失。

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.