Obstructive Sleep Apnea Devices for Out-Of-Center (OOC) Testing: Technology Evaluation

Abstract

Guidance is needed to help clinicians decide which out-of-center (OOC) testing devices are appropriate for diagnosing obstructive sleep apnea (OSA). A new classification system that details the type of signals measured by these devices is presented. This proposed system categorizes OOC devices based on measurements of Sleep, Cardiovascular, Oximetry, Position, Effort, and Respiratory (SCOPER) parameters.Criteria for evaluating the devices are also presented, which were generated from chosen pre-test and post-test probabilities. These criteria state that in patients with a high pretest probability of having OSA, the OOC testing device has a positive likelihood ratio (LR+) of 5 or greater coinciding with an in-lab-polysomnography (PSG)-generated apnea hypopnea index (AHI) ≥ 5, and an adequate sensitivity (at least 0.825).Since oximetry is a mandatory signal for scoring AHI using PSG, devices that do not incorporate oximetry were excluded. English peer-reviewed literature on FDA-approved devices utilizing more than 1 signal was reviewed according to the above criteria for 6 questions. These questions specifically addressed the adequacy of different respiratory and effort sensors and combinations thereof to diagnose OSA. In summary, the literature is currently inadequate to state with confidence that a thermistor alone without any effort sensor is adequate to diagnose OSA; if a thermal sensing device is used as the only measure of respiration, 2 effort belts are required as part of the montage and piezoelectric belts are acceptable in this context; nasal pressure can be an adequate measurement of respiration with no effort measure with the caveat that this may be device specific; nasal pressure may be used in combination with either 2 piezoelectric or respiratory inductance plethysmographic (RIP) belts (but not 1 piezoelectric belt); and there is insufficient evidence to state that both nasal pressure and thermistor are required to adequately diagnose OSA. With respect to alternative devices for diagnosing OSA, the data indicate that peripheral arterial tonometry (PAT) devices are adequate for the proposed use; the device based on cardiac signals shows promise, but more study is required as it has not been tested in the home setting; for the device based on end-tidal CO(2) (ETCO(2)), it appears to be adequate for a hospital population; and for devices utilizing acoustic signals, the data are insufficient to determine whether the use of acoustic signals with other signals as a substitute for airflow is adequate to diagnose OSA.Standardized research is needed on OOC devices that report LR+ at the appropriate AHI (≥ 5) and scored according to the recommended definitions, while using appropriate research reporting and methodology to minimize bias.