SIESTA - Home sleep study with BresoDx for obstructive sleep apnea: a randomized controlled trial

Area of Science:

• Sleep Medicine
• Medical Devices
• Diagnostic Accuracy

Background:

• Obstructive sleep apnea (OSA) diagnosis traditionally relies on polysomnography (PSG).
• Home sleep apnea testing (HSAT) with portable monitors offers a potential alternative.
• Evaluating the accuracy and agreement of HSAT devices like BresoDx is crucial.

Purpose of the Study:

• To assess the accuracy of clinical diagnosis of obstructive sleep apnea (OSA) using the BresoDx portable monitor compared to Type 1 polysomnography (PSG).
• To evaluate the agreement of the apnea-hypopnea index (AHI) between BresoDx and PSG.

Main Methods:

• A randomized, parallel, multicentre, single-blind, pragmatic controlled trial was conducted.
• Adults referred for suspected OSA were randomized to either BresoDx followed by PSG or PSG followed by BresoDx.
• Primary outcomes included diagnostic accuracy and AHI agreement.

Main Results:

• The agreement between clinical diagnoses informed by PSG and BresoDx was fair (Cohen's kappa = 0.28).
• BresoDx demonstrated sensitivity between 0.86-0.89 and specificity between 0.38-0.44 for OSA diagnosis against PSG.
• For an AHI cutoff of ≥5 events/hour, sensitivity was 0.85, specificity 0.48, PPV 0.81, and NPV 0.54.

Conclusions:

• Home sleep apnea testing with BresoDx is suitable for referral populations with high pretest probability of OSA, similar to other Type IV devices.
• This study supports the role of portable home testing devices in diagnosing OSA across various clinical settings.
• BresoDx provides valuable data complementing existing evidence on HSAT efficacy.