ABSTRACT
The SD-101 (Kenzmedico co. Ltd., Saitama, Japan), a non-invasive medical device capable of measuring respiratory parameters during sleep, has recently been developed. It operates while placed under the body like a bed pad equipped with 162 pressure sensors, with the patient in bed. To evaluate the efficacy and safety of the SD-101 for the diagnosis of sleep apnea syndrome (SAS), we enrolled 52 patients with suspected SAS (45 men and 7 women; mean age, 45.6 +/- 10.9 years) in this study. Each subject underwent measurement using the SD-101 and a polysomnograph simultaneously, and we analyzed and compared them. In addition, health-economic benefits of the SD-101 were estimated based on the results. A significantly strong correlation was obtained between the apnea hypopnea index of PSG and its of SD-101 (r = 0.86, p < 0.0001). No adverse event due to the SD-101 occurred, while use of the SD-101 greatly reduced "feeling of being constrained" and discomfort during examination (Wilcoxon test: p < 0.0001). These findings could indicate that the SD-101 is clinically useful and will make a contribution to health-economic benefits for SAS in Japan.
Subject(s)
Equipment and Supplies/standards , Sleep Apnea Syndromes/diagnosis , Adult , Equipment Safety , Equipment and Supplies/economics , Female , Humans , Male , Middle Aged , PolysomnographyABSTRACT
Recently, a noninvasive medical device (SD-101) capable of detecting breathing pattern changes in a subject lying supine or on the side has been developed. We therefore tested whether the SD-101 would be useful for diagnosing sleep apnea syndrome (SAS). Seventy patients who had been suspicious of SAS were enrolled (M/F = 61/9, mean age +/- SD = 46.6 +/- 14.7 y/o). They took 2 distinct screening tests for SAS (using the SD-101 and one of the most popular screeners for SAS in Japan (Apnomonitor III: AP, Chest Co., Tokyo)) and a simultaneously performed standard polysomnography (PSG). All patients were then asked to respond to a questionnaire on awareness of invasiveness experienced during each study (both from the screeners and from the standard PSG). The data were then compared with those from PSG mainly using correlation coefficients and the x2 test for analysis of subjective invasiveness. Statistical significance was defined as a p value of less than 0.05. As a result, the apnea-hypopnea index (AHI) from SD-101 (r=0.947, p<0.0001) had a significantly higher correlation coefficient (p<0.0001) than that from the AP (r=0.601, p<0.0001) in relation to that from PSG. The SD-101 had a significantly lower invasiveness than either AP or PSG (p<0.0001). In conclusion, SD-101 could be much more useful for checking AHI than other conventional screeners, such as AP, which suggests that SD-101 is more useful for defining SAS.
