A novel device (SD-101) with high accuracy for screening sleep apnoea-hypopnoea syndrome

Background and objective: The SD-101 is a non-restrictive, sheet-like medical device with an array of pressure sensors, to detect sleep-disordered breathing by sensing gravitational alterations in the body corresponding to respiratory movements. This study evaluated the accuracy of the SD-101 for screening sleep apnoea-hypopnoea syndrome (SAHS) by comparison with polysomnography. Methods: Nocturnal polysomnography and SD-101 monitoring were conducted simultaneously and compared in 201 patients with suspected SAHS (suspected SAHS group) and 165 male employees of a transport company (screening group). Results: Polysomnography revealed an AHI of <5, 5 <= AHI < 15, 15 <= AHI < 30, 30 <= AHI < 60 and AHI >= 60 events/h in 39, 35, 38, 68 and 21 subjects in the suspected SAHS group and 103, 34, 12, 12 and four subjects in the screening group, respectively. Central SAHS and obstructive SAHS were subsequently diagnosed in 11 (5.5%) and 135 (67.2%) of subjects in the suspected SAHS group and five (3.0%) and 39 (23.6%) of subjects in the screening group, respectively. Significant correlations were apparent between AHI and the respiratory disturbance index (RDI) measured with the SD-101 in both the suspected SAHS group (r = 0.88) and screening group (r = 0.92). Receiver operating characteristic curve analysis revealed 89.5% sensitivity and 85.8% specificity in identifying SAHS, using an RDI of 14.0 events/h. Conclusions: These findings suggest that the SD-101 is a useful device for screening SAHS.