SIESTA - Home Sleep Study with BresoDx for Obstructive Sleep Apnea: A Randomized Controlled Trial

Abstract Study Objectives The objectives of this study were to evaluate 1) the accuracy of the clinical diagnosis of obstructive sleep apnea (OSA) informed by the home sleep study with a Type 4 portable monitor BresoDx ® versus Type 1 polysomnography; and 2) agreement of the apnea-hypopnea index (AHI) compared between BresoDx and polysomnography. Material and Methods This was a randomized, parallel, multicentre, single-blind, pragmatic controlled trial enrolling adults referred to three Ontario sleep clinics for suspected OSA. Participants were randomized to BresoDx followed by polysomnography (one-night apart) or polysomnography followed by BresoDx sleep testing sequence arms. The primary outcomes included the accuracy of clinical diagnosis and OSA severity measured by AHI between tests. Results Two hundred thirty three participants completed both sleep studies and 206 completed physician consultation visits. The agreement between clinical diagnosis informed by PSG versus BresoDx was fair (Cohen’s kappa coefficient=0.28). The sensitivity of BresoDx-informed clinical diagnosis against PSG was between 0.86 and 0.89, and the specificity between 0.38 and 0.44. For AHI cut-off of ≥5 events/hour the sensitivity, specificity and positive and negative predictive values were 0.85, 0.48, 0.81 and 0.54. Conclusions Home sleep apnea testing with BresoDx can be used in a referral population with a high pretest probability of OSA similar to other Type IV devices. This study complements the existing body of evidence suggesting that home testing with portable devices plays a valuable role for diagnosing of OSA in a variety of settings. SIESTA trial registration www.clinicaltrials.gov (Identifier: NCT02003729)