Michael Fitzpatrick1, Valeria E Rac2, Nicholas Mitsakakis3, Lusine Abrahamyan3, Petros Pechlivanoglou4, Suzanne Chung5, Steven M Carcone5, Ba' Pham5, Tetyana Kendzerska6, Merrick Zwarenstein7, Raymond Gottschalk8, Charles George9, Alia Kashgari9, Murray Krahn10. 1. Department of Medicine, Queen's University, Kingston, Ontario, Canada. Electronic address: fitzpatm@kgh.kari.net. 2. Ted Rogers Centre for Heart Research, Peter Munk Cardiac Centre, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada; Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, Ontario, Canada. 3. Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, Ontario, Canada. 4. Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, Ontario, Canada; Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada. 5. Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada. 6. The Ottawa Hospital Research Institute, University of Ottawa, Canada. 7. Department of Family Medicine, Western University, London, Ontario, Canada. 8. Department of Medicine, McMaster University, Hamilton, Ontario, Canada. 9. Department of Medicine, Western University, London, Ontario, Canada. 10. Toronto Health Economics and Technology Assessment (THETA) Collaborative, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
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 (PSG); and (2) agreement of the apnea-hypopnea index (AHI) compared between BresoDx and PSG. 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 PSG (one-night apart) or PSG 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: In sum, 233 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).
RCT Entities:
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 (PSG); and (2) agreement of the apnea-hypopnea index (AHI) compared between BresoDx and PSG. 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 PSG (one-night apart) or PSG 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: In sum, 233 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).