Arnoldo Guerrero1, Cristina Embid2, Valentina Isetta3, Ramón Farre3, Joaquin Duran-Cantolla4, Olga Parra5, Ferran Barbé6, Josep M Montserrat2, Juan F Masa7. 1. Pulmonary and Critical Care Service. Dr. José Eleuterio González University Hospital. UANL. Monterrey, México ; Pulmonary Service. Clínic Hospital. UB-IDIBAPS. Barcelona, Spain. 2. Pulmonary Service. Clínic Hospital. UB-IDIBAPS. Barcelona, Spain ; CIBER de enfermedades respiratorias (CIBERES). Madrid, Spain. 3. CIBER de enfermedades respiratorias (CIBERES). Madrid, Spain ; Unit of Biophysics and Bioengineering. Faculty of Medicine. IDIBAPS. University of Barcelona. Barcelona, Spain. 4. CIBER de enfermedades respiratorias (CIBERES). Madrid, Spain ; Bio-Araba Research Institute and Clinical Research Unit, Hospital Universitario Araba. Vitoria, Spain. 5. CIBER de enfermedades respiratorias (CIBERES). Madrid, Spain ; Pulmonary Service. Sagrat Cor Hospital. Barcelona, Spain. 6. CIBER de enfermedades respiratorias (CIBERES). Madrid, Spain ; Respiratory Dept. IRBLleida. Lleida, Spain. 7. CIBER de enfermedades respiratorias (CIBERES). Madrid, Spain ; Pulmonary Service. Hospital San Pedro de Alcantara. Cáceres. Spain.
Abstract
STUDY OBJECTIVES:Obstructive sleep apnea (OSA) diagnosis using simplified methods such as portable sleep monitoring (PM) is only recommended in patients with a high pretest probability. The aim is to determine the diagnostic efficacy, consequent therapeutic decision-making, and costs of OSA diagnosis using polysomnography (PSG) versus three consecutive studies of PM in patients with mild to moderate suspicion of sleep apnea or with comorbidity that can mask OSA symptoms. DESIGN AND SETTING: Randomized, blinded, crossover study of 3 nights of PM (3N-PM) versus PSG. The diagnostic efficacy was evaluated with receiver operating characteristic (ROC) curves. Therapeutic decisions to assess concordance between the two different approaches were performed by sleep physicians and respiratory physicians (staff and residents) using agreement level and kappa coefficient. The costs of each diagnostic strategy were considered. PATIENTS AND RESULTS:Fifty-six patients were selected. Epworth Sleepiness Scale was 10.1 (5.3) points. Bland-Altman plot for apnea-hypopnea index (AHI) showed good agreement. ROC curves showed the best area under the curve in patients with PSG AHI ≥ 5 [0.955 (confidence interval = 0.862-0.993)]. For a PSG AHI ≥ 5, a PM AHI of 5 would effectively exclude and confirm OSA diagnosis. For a PSG AHI ≥ 15, a PM AHI ≥ 22 would confirm and PM AHI < 7 would exclude OSA. The best agreement of therapeutic decisions was achieved by the sleep medicine specialists (81.8%). The best cost-diagnostic efficacy was obtained by the 3N-PM. CONCLUSIONS: Three consecutive nights of portable monitoring at home evaluated by a qualified sleep specialist is useful for the management of patients without high pretest probability of obstructive sleep apnea or with comorbidities. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov, registration number: NCT01820156. CITATION: Guerrero A, Embid C, Isetta V, Farre R, Duran-Cantolla J, Parra O, Barbé F, Montserrat JM, Masa JF. Management of sleep apnea without high pretest probability or with comorbidities by three nights of portable sleep monitoring.
RCT Entities:
STUDY OBJECTIVES:Obstructive sleep apnea (OSA) diagnosis using simplified methods such as portable sleep monitoring (PM) is only recommended in patients with a high pretest probability. The aim is to determine the diagnostic efficacy, consequent therapeutic decision-making, and costs of OSA diagnosis using polysomnography (PSG) versus three consecutive studies of PM in patients with mild to moderate suspicion of sleep apnea or with comorbidity that can mask OSA symptoms. DESIGN AND SETTING: Randomized, blinded, crossover study of 3 nights of PM (3N-PM) versus PSG. The diagnostic efficacy was evaluated with receiver operating characteristic (ROC) curves. Therapeutic decisions to assess concordance between the two different approaches were performed by sleep physicians and respiratory physicians (staff and residents) using agreement level and kappa coefficient. The costs of each diagnostic strategy were considered. PATIENTS AND RESULTS: Fifty-six patients were selected. Epworth Sleepiness Scale was 10.1 (5.3) points. Bland-Altman plot for apnea-hypopnea index (AHI) showed good agreement. ROC curves showed the best area under the curve in patients with PSG AHI ≥ 5 [0.955 (confidence interval = 0.862-0.993)]. For a PSG AHI ≥ 5, a PM AHI of 5 would effectively exclude and confirm OSA diagnosis. For a PSG AHI ≥ 15, a PM AHI ≥ 22 would confirm and PM AHI < 7 would exclude OSA. The best agreement of therapeutic decisions was achieved by the sleep medicine specialists (81.8%). The best cost-diagnostic efficacy was obtained by the 3N-PM. CONCLUSIONS: Three consecutive nights of portable monitoring at home evaluated by a qualified sleep specialist is useful for the management of patients without high pretest probability of obstructive sleep apnea or with comorbidities. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov, registration number: NCT01820156. CITATION: Guerrero A, Embid C, Isetta V, Farre R, Duran-Cantolla J, Parra O, Barbé F, Montserrat JM, Masa JF. Management of sleep apnea without high pretest probability or with comorbidities by three nights of portable sleep monitoring.
Entities:
Keywords:
CPAP; comorbidities; home respiratory polygraphy; obstructive sleep apnea; polysomnography
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