Polysomnography validation of SANSA to detect obstructive sleep apnea

Area of Science:

• Sleep Medicine
• Cardiology
• Medical Devices

Background:

• Obstructive sleep apnea (OSA) is a prevalent condition requiring accurate diagnosis.
• Home sleep apnea testing offers a convenient alternative to in-lab polysomnography (PSG).
• Novel devices integrating multiple physiological measurements may enhance diagnostic capabilities.

Purpose of the Study:

• To evaluate the diagnostic performance of the SANSA home sleep apnea test, which includes an embedded electrocardiogram (ECG).
• To assess the agreement between SANSA and PSG for diagnosing OSA.
• To determine the accuracy of SANSA in measuring total sleep time (TST).

Main Methods:

• A prospective multicenter validation study involving 340 participants.
• Simultaneous recording using SANSA and PSG across 7 clinical sites.
• Analysis of apnea-hypopnea index (AHI) and TST, comparing SANSA with consensus PSG scores using correlation and Bland-Altman methods.

Main Results:

• SANSA demonstrated excellent agreement with PSG for AHI (correlation 0.90-0.91) and TST (R=0.82).
• The device achieved 88% sensitivity and 87% specificity for detecting moderate-to-severe OSA (AHI ≥15 events/h) using Rule 1B.
• Sleep epoch classification accuracy was 87.2%.

Conclusions:

• The SANSA home sleep apnea test shows robust diagnostic performance for OSA detection and sleep measurement.
• Its ease of use and integrated ECG provide potential for multi-diagnostic applications in sleep medicine and cardiology.
• The device is suitable for diverse clinical populations, aiding in the detection of OSA and cardiac arrhythmias.