SBIR-STTR Award

The goal of this research is to create a device, called the Actillume, that can monitor on a continuous, long-term basis the motor activity of a patient concurrently with the light exposure of the patient. The importance of light exposure in affective and certain sleep disorders (delayed sleep-phase syndrome) makes clear the value of illumination monitoring for both psychiatric research and treatment evaluation. In this project, it is planned to further develop and test a combined activity and illumination monitor that can be worn on the wrist. The miniature design allows the patient to wear this device for several days and nights to collect data on affective disorders, such as jet lag or insomnia due to shift work.The project will develop a clinical working unit based on preliminary breadboard design, and will test and package the unit with a microprocessor and programs that will enable the operation of the Actillume in busy clinical settings. The work program entails internal software and interface boards within a computer frame for initializing and dumping data. Other software programs will be developed to display and analyze the data and to provide the information in a format for clinical use.In Phase II, it is planned to develop software and validate the relationship of light exposure and activity as a clinical management tool in a large patient sample.

Anticipated Results:
Continuous monitoring of light exposure levels and motor activity can provide significant information regarding the sleep/wake cycle and light exposure of the wearer. Light exposure and light therapy have been shown to affect certain types of depressed patients. Treatment with light therapy is beneficial in certain affective diseases and can minimize the effect of shift work, jet lag, and rotation.National Institute Of Mental Health (NIMH)

This Phase II proposal will perform the validation, testing, and software development for a commercially acceptable Actillume instrument. We will revalidate improved sensor designs, an external photo transducer, and new calibration protocols. A new user-friendly software package will be developed for device initialization, data recovery, data editing, plotting, and statistical analyses. An automated clinical report will be developed. A user procedure manual will be written. Human engineering will be evaluated through use-testing with a variety of research subjects and sleep clinic patients. In addition, to provide preliminary normal ranges for clinical use, 50 subjects will be monitored in San Diego and 50 subjects will be monitored in Rochester, Minnesota in each of the 4 seasons of the year. Consortium agreements with the University of California, San Diego and the Mayo Clinic will support these studies. Phase II will produce an Actillume system for studies of sleep disorders patients, affective disorders, elderly, premenstrual syndrome, shift work, jet lag, the chronically ill, etc. Enthusiasm for the device indicates a substantial market. In Phase III, quantity production will permit lower-cost production.