The finished iBrain will be wireless and will report data during the night to NeuroVigil’s data centers via one’s own laptop, via the internet, or perhaps via the device itself.
THE SOLUTION: TECHNOLOGY, INGENUITY, BRILLIANCE
The NeuroVigil technology comprises both patent-pending and proprietary elements that the company is developing for both product and service offerings.
The SPEARS Algorithm
By taking a single channel of EEG, SPEARS creates a map of brain activity, wherein waking and sleep stages have different signatures. SPEARS can represent a night’s worth of brain activity in clusters, where every sleep and waking state forms a separate cluster. SPEARS can reliably extract a maximal number of stages in minimal time, using a single channel. This means there is no longer a need for 16, 8, or even 2 channels when undergoing an EEG. This also means that no human needs to visually review all data in all those traces. Together, this creates the opportunity for a small, single-channel EEG system that can be performed anywhere, even while driving. Comparison of manual sleep test scoring with automatic scoring from the SPEARS algorithm shows no difference except in the large amount of time and labor saved. The resolution and power of SPEARS has revealed a new sleep state which can actually be used to test for genetic similarity. This is the first non-DNA test to do so.
Providing SPEARS to the Industry and Consumer
The NeuroVigil Business Plan is based on addressing three key markets that will require two technology development programs. The Sleep Lab Automation and Biopharmaceutical Clinical Trial Sleep Servicing will require development of a server platform and client application that will implement data collection, storage, process and reporting algorithms.
The server will be run at NeuroVigil and will receive and send secure transmissions via the internet, in compliance with HIPAA standards for data transmission and encryption regarding patient information. The server will be responsible for receiving all inbound patient history, physical data, EEG data and other continuous waveform data. The server will also perform all data conversion, analysis, and interpretation using the SPEARS and other proprietary algorithms to generate data and reports that will be sent back to the user’s client application. Transmission will be encrypted and will comply with HIPAA standards.
The server will interface with a client or user interface that will be run on a client’s workstation, either at a sleep center, hospital, or other patient care site. The server will also maintain data regarding transaction history, user access records, and transmission history. The client server will provide both a turnkey local data management and reporting solution, visualization and viewer solution, and will interface with currently available and deployed software for EEG viewing. We expect to involve sleep specialists and technicians in the design, prototyping, and beta testing of the client application.
The Sleep Lab Platform
The Sleep Lab market is split between at-home testing and facility testing. Facility testing either is performed in hospital, laboratory, or private sleep clinic settings. A typical sleep laboratory has approximately $50-$100K of expenses per bed, but runs between 3 and 6 sleep studies per week per bed.
Pharmaceutical Clinical Testing Services
NeuroVigil plans to assist pharmaceutical companies testing the effects of generic and sleep inducing drugs on brain activity. Many drugs are known to affect sleep even though these have initially been developed for other purposes. Anti-depressants, the most prescribed drugs in the US, are known to profoundly affect the latency and duration of REM sleep. However little is known about the effect of these and other drugs on high frequency components of brain activity, as these had been thought to be inaccessible by EEGs. A focus of NeuroVigil’s clinical program will be to assist drug companies in isolating hidden high frequency drug induced contaminations of brain activity, before these drugs are commercialized. Drugs are usually recalled only when they are suspected to cause a behavioral deficit, such as amneasia and violence (Upjohn’s Halcion is a good example) or when their effect does not wear off rapidly enough (“sleep driving”). NeuroVigil is currently exploring assisting with several drug companies, including Novartis.
The iBrain: A device for sleep monitoring and diagnosis at home
Many clinicians view home sleep studies as screening tools to determine which individuals needs sleep laboratory studies, but with Medicare’s recent approval of these studies, many expect the number of at home studies to dramatically increase and their use to be considered not merely screening but diagnostic for a number of disorders, including sleep apnea. Fortunately for NeuroVigil, devices currently available are limited in their ability to acquire adequate EEG data (SPEARS does not require for movement artifacts to be manually labeled). The additional signals required in traditional scoring of a sleep study are less difficult to analyze and have been automated by many companies and are part of the scoring platform marketed by Compumedics and Puritan Bennett.
The iBrain: A transportation safety device
Newer technologies will be developed in order to convert SPEARS into an online algorithm, incorporated into hardware which will be used to detect vigilance changes in real time. The single channel capability of SPEARS will minimize the burdens on the hardware and therefore also on the people wearing it.
We plan to make these kinds of devices available to the transportation industry, biofeedback and defense. Applications regarding pandemics and bioterrorism are being considered but cannot be shared in this format.