SBIR-STTR Award

This is a revision of a previous Phase I proposal. The proposed goal is to show feasibility for developing a wearable "artificial labyrinth" which provides patients with dizziness information about movement by maintaining a level horizon in a visual display. The overall goal is to control symptoms of motion sickness and to shorten the rehabilitative process in patients with dizziness. A questionnaire and rating scales will be used to assess feasibility and ease of use, and to obtain preliminary data regarding safety and efficacy. A major emphasis will be on software development and hardware design, to demonstrate the feasibility of a wearable device that can be tested clinically. Twenty patients with motion sickness will wear the device in situations that provoke their symptoms. Additional twenty patients with vertigo or dizziness from other causes will wear the device during vestibular rehabilitation therapy. The intended ultimate product is a wearable device, combined with a program and manual for its use in various conditions, including motion sickness and vestibular rehabilitation.

Postural control requires a complex interaction of visual and proprioceptive sensory inputs in addition to that provided by the vestibular system. A discrepancy produces a sensory mismatch and can result in seasickness, airsickness, and virtual reality or simulator sickness. In a prior Phase I study, a fully wearable artificial labyrinth prototype was developed and showed feasibility as an aid in controlling the symptoms of motion sickness and in the rehabilitative process in patients with dizziness following vestibular nerve section or removal of a skull base lesion such as acoustic tumor. The device works by providing visual information about movement using an artificial horizon. This Phase II study is intended to result in device improvements, including lighter weight, lower power consumption, integration of the eyepiece so that the device will be one integrated unit, and development of a sensor to make the device more affordable; that is, to develop a clinically functional device, along with instructional materials for its use. It will be tested clinically in 25 subjects with motion sickness, who will complete rating scales regarding its usefulness, and 25 subjects with vertigo or dizziness undergoing vestibular rehabilitation. The latter will be assessed before and after use of the device with measures of vestibular function and will be compared to a control group of 25 patients undergoing vestibular rehabilitation who do not use the device. The high prevalence of motion sickness, in the public and among military personnel, and the possibility that a visual aid may help to overcome these problems as well as speed up the compensation process in vestibular rehabilitation for patients with dizziness of other origins provides a commercial opportunity for a device such as the wearable artificial labyrinth