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Itamar Medical Ltd.
APPENDIX E: CENTRAL SLEEP APNEA SYNDROME DETECTION
The efficacy of the WP200U in the detection of AHIc for a threshold of 10 was evaluated in a
multi-center study in 72 patients and the following results were obtained:
• Sensitivity = 70.6%
• Specificity = 87.3%
• Positive predictive value (PPV) = 63.2%
• Negative predictive value (NPV) = 90.6%
In addition, the following statistics was demonstrated:
Area Under the Curve (AUC) = 0.873 of a ROC for a PSG threshold of AHIc = 10
Pearson correlation between AHIc of PSG and WP200U of R=0.83 with a slope of 0.91 and offset
of 0.26.
ADDITIONAL NON-DIAGNOSTIC INFORMATION
The efficacy of the WP200U in the assessment of %CSR (Cheyne Stokes Breathing) pattern
was evaluated in a sub-group of 17 patients that were found to have AHIC≥10 by the PSG on a
standard 30 seconds epoch-by-epoch comparison . A total of 10,509 aggregated epochs were
derived from these patients and the following results were obtained:
• Sensitivity = 51.3%
• Specificity = 93.7%
• Positive Predictive Value (PPV) = 78.4%
• Negative Predictive Value (NPV) = 81.3%
• Overall Agreement = 80.7%
Source of Data
Study Title:
Diagnosis of Sleep-related Respiratory Disorders in patients suspected of
having SDB with and without cardiac disorders
Date of the Report: May 25, 2016
Principal Investigator(s): Prof. Giora Pillar (Carmel Medical Center)
Sponsor: Itamar Medical, Ltd. 9 Halamish St POB 3579, Caesarea 3088900 Israel
Device(s):
Watch PAT 200U (WP200U)
Study Period:
September 5, 2015 to February 24, 2016
National Clinical Trial (NCT) Numbers: NCT02369705, NCT01570738
NOTE:
The AHIc and %CSR were validated in a clinical study using the WP200U device
having the same analysis that is used with the WatchPAT device.
WatchPAT™ONE System
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Operation Manual
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