title: A novel device (SD-101) with high accuracy for screening sleep apnoea-hypopnoea syndrome.
abstract: 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 < or = AHI < 15, 15 < or = AHI < 30, 30 < or = AHI < 60 and AHI > or = 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.
authors.affiliation: First Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Nagano 390-8621, Japan.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Agatsuma
authors.forename: Keisaku
authors.initials: K
authors.lastname: Fujimoto
authors.forename: Yoshimichi
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Urushihata
authors.forename: Takayuki
authors.initials: T
authors.lastname: Honda
authors.forename: Teruomi
authors.initials: T
authors.lastname: Tsukahara
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Nomiyama
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004864:Equipment and Supplies; D005260:Female; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation / Q000379:methods*; D017286:Polysomnography / Q000295:instrumentation / Q000379:methods; D015656:Respiratory Mechanics / Q000502:physiology; D012680:Sensitivity and Specificity; D012891:Sleep Apnea Syndromes / Q000175:diagnosis* / Q000503:physiopathology*; D055815:Young Adult