A wireless wearable system is proposed to assess adherence to study protocols for complementary and alternative medicine (CAM) mind-body interventions. This system will utilize recently developed silicon micro machined sensors for measuring the gravity vector (accelerometers) and angular rates (gyroscopes). Data will be collected in real time from these sensors using a low power digital wireless network technology called Bluetooth. The Bluetooth network is a standard that is now available in many commercially available handheld computers and smart cell phones. The use of Bluetooth will allow a researcher to invest in a set of sensors that will be compatible with new portable computing and cell phone devices for many years to come. In a study protocol that uses mind body interventions such as meditation, yoga and tai chi, the small wireless sensor packages are worn on the body. Between 1 to 7 sensor packages can be used. A subject wears the sensors during the training for the study protocol. This is used to collect a baseline set of body movements. During the course of the study, the sensors are worn during the mind-body interventions. The 3 axis of acceleration and angular rate sensing information at each sensor location is transmitted to a handheld computer or smart cell phone. This recorded data can be used to compare the deviations both spatially and temporally from the baseline dataset to determine a compliance index. Both static state and change of state deviations can be measured and quantified. A report will be generated with analysis software that shows an index in percentage of deviations in segments of the protocol that the research is interested in monitoring. The phase I project will develop a prototype set of hardware sensors and software for the system. A human study will be conducted to test the functional operation of the system in a mind-body study protocol. Project Narrative: Determining the safety and efficacy of any intervention is vital. Understanding and accurately measuring the extent to which patients and study participants adhere to research protocols is essential information for accurate assessment of outcomes. Mind-body interventions require substantial participant adherence to specific study protocols. Research projects examining the health effects of meditation, yoga, tai chi, and similar interventions require participants to regularly engage in these practices on their own in specific formats and under specified protocols. Assessing the level of participant adherence to these protocols is essential in order to understand the dose, the efficacy, the safety, and the feasibility of the intervention. ? ? ? ?
