PURPOSE: Validation of a software device enabling diagnosis of Sleep Related Breathing Disorder and Sleep Architecture and quality based on single channel ECG and pulse oximetry recordings only.
METHODS: Recordings from 54 randomly selected patients from a cohort Chronic Fatigue Syndrome study at the CDC and 50 subjects from consecutive patients referred for PSG at Share Zedek Medical Center in Jerusalem. All recordings were standard PSG and were scored manually according to Rechtschaffen & Kales and ASDA criteria. The ECG and pulse oximtery signals were separately and blindly analyzed by the software HC1000P, to determine sleep time, sleep efficiency, % time awake, %NREM and% REM sleep, and respiratory disturbance index (RDI).
RESULTS: 102 of 104 PSGs contained technically acceptable signals. There was no significant (t test) difference between ECG and PSG derived values of total sleep time (391.5+62.8 vs 387.7 ± 31.6 minutes), sleep efficiency (84.6% ± 10.4% vs 82.7% ± 4.5%), wake (54.3 ± 39.5 vs 58.5 ± 19 minutes), NREM (322.1 ± 52.5 vs 319.0 ± 29.8 minutes), and REM sleep (72.9 ± 33.8 vs 68.7 ± 25.2 minutes). Comparisons between RDI obtained by the two methods, yielded a correlation coefficient of R=0.92. When RDI values are divided into two groups, low and high RDI with the cutoff at 15 events per hour, and utilizing ROC analysis to determine the optimal point of division for HC RDI, there results a 98.0% match-up between RDI and HC RDI results. Cohen's Kappa is 0.96, both specificity and sensitivity are 0.98.
CONCLUSION: No significant differences between sleep architecture and RDI obtained by the 2 methods were detected. The new method provides reliable and reproducible diagnosis of sleep disordered breathing.
CLINICAL IMPLICATIONS: HC1000P will facilitate high throughput analysis of sleep/wake parameters and RDI.
DISCLOSURE: Clement Cahan, Shareholder Shareholder and employee of HypnoCore LTD, the manufacturer of the software; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. HC1000P a software product for sleep related breathing disorders based on ECG and oxygen saturation