Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

描述(申请人提供)：这项拟议的研究将开发一种可穿戴的意识增强和监测设备(AEMD)，该设备将有助于治疗毛发狂症，这是一种反复出现的拔毛障碍，会导致明显的脱发。该设备将监测手和受影响的头发之间的相对身体位置，通过在拉动之前使用振动和/或声音向用户发出信号来产生意识。该设备将具有监控功能，允许用户将每一次手与身体接触事件的性质归类为头发拉扯、险些拉扯或偶然触摸。这些事件及其分类将被记录下来，并加盖时间和日期戳，并下载到个人计算机上进行分析和图形显示。该设备可以在激活警报和监控功能的情况下运行，也可以在没有警报功能的情况下简单地监控行为。拟议的第一阶段设备是一个小型信号装置，它将有触发元件佩戴在头部附近，包含传感器和蓝牙TM射频通信的元件佩戴在手上或附近，以及警报、蓝牙TM射频通信和数据记录元件(启用蓝牙TM的商用个人数据助理-PDA)佩戴在腰部或口袋中。在第一阶段，将开发和测试原型，测试其尺寸、重量和电池寿命，以及在手和头之间以编程的距离/持续时间发出信号的能力，以及其他功能。它将对附带的射频干扰没有反应，只有当触发器进入警报区时才发出信号。该设备具有用户可调的时间延迟功能。希望最早中断习惯的用户可以选择无延迟选项，而那些对“假警报”敏感的用户可以在设备触发警报之前设置定制的时间延迟。该设备将允许用户激活临时休假功能，从而实现非破坏性的手到头功能(例如刷牙)。在第一阶段，原型将在9名人体受试者身上进行测试。在第二阶段，这项技术将继续为微型化和可制造性而开发，我们将通过对脱毛症患者进行人体研究来扩展这一研究机构，以确定该设备的疗效。到目前为止的研究表明，药物和行为疗法虽然有帮助，但会让许多人出现临床上明显的头发拉扯，需要进一步的帮助。该设备最初的商业应用将针对美国180多万毛躁症患者，预计它将与现有的行为疗法一起使用。除了为毛发狂症提供一种新的治疗方法外，拟议中的设备或改良版本还可以用来帮助治疗其他以身体为重点的重复行为问题，如挑皮肤、咬手指和咬指甲。这项拟议的研究的目标是开发一种设备来帮助毛发狂症患者，毛发狂症是一种非常严重的、通常没有诊断和治疗的问题，涉及强迫性拔头发。这个设备将帮助患者意识到他们的头发拉，并将监测这种破坏性习惯的频率和持续时间。现有的心理治疗只有部分帮助，这种装置如果与目前的治疗相结合，可以极大地改善患者及其家人的生活。

DESCRIPTION (provided by applicant): The proposed research will develop a wearable awareness enhancement and monitoring device (AEMD) which will assist the treatment of trichotillomania, a repetitive hair pulling disorder that leads to noticeable hair loss. The device will monitor relative body position between the hand and the effected hair, creating awareness by signaling the user, using vibration and/or sound, prior to pulling. The device will have monitoring capabilities which will allow for users to classify the nature of each hand to body touching incident as a hair pull, a near pull, or as an incidental touch. These incidents and their classification will be logged with a time and date stamp and downloaded to a personal computer for analysis and graphic presentation. The device can function with both the alert and monitoring features activated or it can simply monitor behaviors without the alarm feature. The proposed Phase I device is a small signaling mechanism which will have triggering elements worn near the head, elements containing a sensor and Bluetoothtm RF communication worn on or near the hands, and an alarm, Bluetoothtm RF communication and data logging element (a Bluetoothtm enabled commercially available personal data assistant - PDA) worn at the waist or in a pocket. During Phase I, prototypes will be developed and tested for size, weight and battery life, the ability to signal at programmed distances/durations between the hand and head, and for other functions. It will be non-responsive to incidental RF interference, signaling only when the trigger enters the alarm zone. The device has a user-adjustable time delay feature. Users who wish earliest possible habit interruption can select a no delay option whereas those who are sensitive to "false alarms" can set a customized time delay before the device triggers an alert. The device will allow the user to activate a temporary time-off feature allowing for non-destructive hand to head functions (e.g. tooth brushing). Prototypes will be tested on nine human subjects in Phase I. In Phase II, the technology will continue to be developed for miniaturization and manufacturability and we will extend this body of research with human studies conducted on individuals with trichotillomania to determine the efficacy of the device. Research to date suggests that medications and behavior therapy, while helpful, leave many individuals with clinically significant hair pulling and in need of further help. The initial commercial application of the device will be aimed at the 1.8 million plus individuals with trichotillomania in the United States, and it is expected be used in conjunction with existing behavioral therapies. In addition to offering a new treatment for trichotillomania, the proposed device, or modified versions, could be used to help treat other body-focused repetitive behavior problems such as skin picking, finger and nail biting. The goal of the proposed research is to develop a device to assist persons with trichotillomania, a very impairing, commonly undiagnosed and untreated problem involving compulsive hair pulling. This device will help sufferers gain awareness of their hair pulling and will also monitor the frequency and duration of this destructive habit. Available psychological treatments are only partially helpful and this device when integrated with current treatments could substantially improve the lives of sufferers and their families.