Real-Time Melatonin Monitor to Diagnose Sleep Disorders

实时褪黑激素监测仪诊断睡眠障碍

• 批准号: 6401739
• 负责人: HAL C CANTOR
• 金额: $ 9.96万
• 依托单位: ADVANCED SENSOR TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-19 至 2002-03-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6401739
• 关键词: aging; biomedical equipment development; blood chemistry; clinical biomedical equipment; clinical research; consumable /disposable biomedical equipment; human subject; mass screening; melatonin; noninvasive diagnosis; nontherapeutic iontophoresis; patient monitoring device; semiconduction; sleep disorders; technology /technique development; time resolved data; transdermal drug delivery

With an ever-growing elderly population, it is becoming increasingly important to monitor physiological correlates associated with age. One major problem associated with age revolves around quantity and quality of sleep. Many commercial devices monitor physiometric nocturnal activity (i.e. actigraphy, EEG, EMG, EOG, respiration, etc.), however, there are no commercial devices available for continuous, non-invasive, near real-time monitoring of chemicals in the blood. The pineal hormone, melatonin, follows a characteristic circadian temporal pattern. Plasma melatonin concentrations are utilized as a correlate indicating sleep, and exogenous application has been utilized in the attempt to improve the quality and quantity of sleep. Contemporary studies on the causal effects of melatonin on sleep require drawing of blood, saliva, or urine, however, each of these techniques require effort on the part of the subject, causing deviation from normal sleep patterns. AST proposes to develop a continuous, near real-time, non-invasive monitor for blood borne chemicals, including melatonin (as well as a myriad of other biological molecules), obtained during activity or sleep. This device will be amenable to mass screening of the elderly (and pediatric) population, with the potential for actuator regulated exogenous melatonin administration. PROPOSED COMMERCIAL APPLICATIONS: In addition to utilization for the study of sleep disorders in elderly patients, this device has the potential to monitor concentrations of electrolytes, hormones, therapeutic drugs, drugs of abuse, and environmental toxins in active ambulatory adults and children. Semiconductor manufacture is amenable to mass production at very low cost. This disposable device will be available for the clinical and home health care markets. Long term sales are estimated to be in the millions per year.

随着老年人口的不断增长，监测与年龄相关的生理相关性变得越来越重要。与年龄相关的一个主要问题与睡眠的数量和质量有关。许多商业设备监测夜间生理活动（即体动记录仪、脑电图、肌电图、眼电图、呼吸等），但是，没有商业设备可用于连续、非侵入性、近乎实时地监测血液中的化学物质。松果体激素、褪黑激素遵循典型的昼夜节律时间模式。血浆褪黑激素浓度被用作指示睡眠的相关物，并且已经利用外源性应用来尝试改善睡眠的质量和数量。当代关于褪黑激素对睡眠因果影响的研究需要抽取血液、唾液或尿液，然而，这些技术中的每一种都需要受试者付出努力，从而导致偏离正常的睡眠模式。 AST 提议开发一种连续、近实时、非侵入性的监测器，用于监测活动或睡眠期间获得的血液化学物质，包括褪黑激素（以及无数其他生物分子）。该设备将适合对老年人（和儿童）人群进行大规模筛查，并具有执行器调节外源褪黑激素管理的潜力。拟议的商业应用：除了用于研究老年患者的睡眠障碍外，该设备还有可能监测活跃的非卧床成人和儿童的电解质、激素、治疗药物、滥用药物和环境毒素的浓度。半导体制造能够以非常低的成本进行大规模生产。该一次性设备将用于临床和家庭医疗保健市场。长期销售额预计每年数百万。