Evaluation of a portable device based on peripheral arterial tone for unattended home sleep studies.
BACKGROUND
Diagnosis of obstructive sleep apnea syndrome (OSAS) by ambulatory systems is a growing practice in view of the large number of patients awaiting correct diagnosis. The Watch PAT100 (WP100) [Itamar Medical; Caesarea, Israel] is a portable device based on the peripheral arterial tone (PAT) signal, and is designed for unattended home sleep studies.


OBJECTIVE
To evaluate the efficacy, reliability, and reproducibility of the WP100 device for the diagnosis of OSAS as compared to in-laboratory, standard polysomnographic-based manual scoring.


METHODS
One hundred two subjects (78 men; 69 patients with OSAS and 33 normal volunteers; mean +/- SD age, 41.4 +/- 15.2 years; body mass index, 26.8 +/- 5.5) underwent in-laboratory full polysomnography simultaneously with WP100 recording. Fourteen subjects also underwent two additional unattended home sleep studies with the WP100 alone. The polysomnography recordings were blindly scored for apnea/hypopnea according to the American Academy of Sleep Medicine criteria (1999), and the polysomnography respiratory disturbance index (RDI) [PSG-RDI] was calculated. The WP100 data were analyzed automatically for the PAT RDI (PRDI) by a proprietary algorithm that was previously developed on an independent group of subjects.


RESULTS
Across a wide range of RDI levels, the PRDI was highly correlated with the PSG-RDI (r = 0.88, p < 0.0001), with an area under the receiver operating characteristic curve of 0.82 and 0.87 for thresholds of 10 events per hour and 20 events per hour, respectively. The PRDI scores were also highly reproducible, showing high correlation between home and in-laboratory sleep studies (r = 0.89, p < 0.001).


CONCLUSIONS
The WP100 may offer an accurate, robust, and reliable ambulatory method for the detection of OSAS, with minimal patient discomfort.
Bar
Amir
A
Itamar Medical Ltd., Caesarea, Israel.
Pillar
Giora
G
Dvir
Itsik
I
Sheffy
Jacob
J
Schnall
Robert P
RP
Lavie
Peretz
P
D000328:Adult; D000465:Algorithms; D001331:Automation; D005260:Female; D006439:Hemodynamics; D006801:Humans; D008297:Male; D018670:Monitoring, Ambulatory / Q000295:instrumentation* / Q000379:methods*; D010991:Plethysmography / Q000295:instrumentation* / Q000379:methods*; D017286:Polysomnography; D012372:ROC Curve; D015203:Reproducibility of Results; D016037:Single-Blind Method; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis* / Q000503:physiopathology