CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
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Comparison of the NovaSom QSG, a new sleep apnea home-diagnostic system, and polysomnography.

BACKGROUND: Obstructive sleep apnea (OSA) is a serious, common, and underdiagnosed disorder that challenges health care resources. While polysomnography (PSG) represents the standard diagnostic test for OSA, portable devices provide an alternative diagnostic tool when issues of cost, time, geographic availability, or other constraints pose impediments to in-lab testing. This study compares the NovaSom QSG, a new sleep apnea home diagnostic system, to PSG both in the laboratory and in the home.

METHODS: Fifty-one consecutive adults referred to the sleep lab for suspicion of OSA underwent one night of in-lab, simultaneous recording of PSG and NovaSom QSG in addition to using the NovaSom QSG at home for three nights. Two separate comparisons were made using the apnea-hypopnea index (AHI): in-lab PSG to in-lab NovaSom QSG and in-lab PSG to home NovaSom QSG.

RESULTS: Using a clinical cut-off of AHI=15, the sensitivity and specificity of the in-lab NovaSom QSG vs. PSG were 95% and 91%, respectively. For home NovaSom QSG vs. in-lab PSG, the sensitivity was 91% and specificity was 83%. The intra-class correlation coefficient for the agreement between three separate nights of NovaSom QSG home data was 0.88.

CONCLUSIONS: In a patient population suspected of having OSA, the NovaSom QSG demonstrated acceptable sensitivity and specificity both in the lab and self-administered in the home, when compared to PSG.

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