Clinical usefulness and health-economic benefits of a new sheet-like medical device (SD-101) for the diagnosis of sleep apnea syndrome

Yuuji Takasaki, Yasuyuki Kaneko, Hiroki Sakakibara, Fumihiko Sasaki, Yasuhiro Uchiyama, Yuuki Mieno, Akira Murata, Shoji Kudoh

Research output: Contribution to journalArticlepeer-review

8 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)181-188
Number of pages8
JournalNihon Kokyūki Gakkai zasshi = the journal of the Japanese Respiratory Society
Volume46
Issue number3
Publication statusPublished - 03-2008
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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