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SAFETY INFORMATION AND INTRODUCTION
A. About the Apnea Risk Evaluation System (ARES)
The Apnea Risk Evaluation System (ARESTM) provides an integrated approach to assist
in the diagnosis of obstructive sleep apnea (OSA). The ARES design combines existing
knowledge on sleep-disordered breathing with an easy-to-apply data acquisition
system. The ARES employs a multivariate approach combining physiological recordings
acquired during sleep with anthropomorphic and clinical information obtained from a
s t a n d a r d i z e d q u e s t i o n n a i r e . T h e A R E S in t e g r a te s : a ) a s e l f - a p p l i e d , s i n g l e s i te ( f o r e h e a d )
device to record continuous full-disclosure physiological signals during sleep in any en-
environment, b) a focused, validated questionnaire, c) automated software to recognize
and quantify abnormal respiratory events, and d) an expert system which utilizes this
information to identify levels of severity of OSA. By combining physiological data,
questionnaire responses, and expert pattern recognition software, the ARES is
designed to provide an accurate and valid assessment of sleep-disordered breathing
that is easily self-administered.
The ARES is a miniaturized recorder capable of recording oxygen saturation, pulse
rate, snoring level, head position/movement, and nasal pressure.
The ARES is easily placed on the forehead by the user and comfortably worn for 8-10
hours. The ARES provides sufficient battery capacity for two nights of recordings
(after seven continuous hours of recording the ARES conserves power by
automatically going into “sleep mode”). The battery must be recharged after
each use.
The ARES monitors signal quality during data acquisition, and notifies the user via a
voice prompt when adjustments are required. Several disposable components must be
replaced, and the forehead sensor cleaned before reuse.
The ARES Questionnaire is used to gather information about risk factors for sleep
apnea, including gender, body mass index, neck circumference, daytime drowsiness
(e.g., Epworth sleepiness score), frequency of snoring, observed apneas, and history of
hypertension or diabetes. The ARES applies patented algorithms to calculate SpO2 and
quantify the occurrence and severity of desaturation events and associated arousals
(based on changes in pulse rate, head movement, snoring sounds and/or airflow). The
ARES system software analyzes the ARES Questionnaire responses and assigns risk
levels of no, low, or high risk for OSA. A summary report provides information useful to
physicians in diagnosing obstructive sleep apnea.
