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A2008 - Validity and Cost-Efectiviness of Pediatric Home Respiratory Poligraphy for the Diagnosis of Obstructive Sleep Apnea: Rationale, Designv the Diagnosis of Obstructive Sleep Apnea: Rationale, Design and Methodology
Author Block: J. Duran-Cantolla1, E. Oceja1, A. Alvarez2, B. Muria2, F. Pumarola3, J. M. Roman-Sanchez4, S. Terceros5, G. del-Rio-Camacho6, A. Navazo7, M. del-Olmo8, E. García Ledesma9, M. Martinez10, T. Luna11, A. Crespo12, L. Gozal13, D. Gozal13, M. Ruiz-de-Valbuena14; 1Research, OSI Araba University Hospital, Vitoria, Spain, 2Sleep Unit, OSI Araba University Hospital, Vitoria, Spain, 3Otorhinolaryngology, Valle de Hebrón University Hospital, Barcelona, Spain, 4Respiratory, Guadalajara University Hospital, Guadalajara, Spain, 5Neurophysiology, OSI Araba University Hospital, Bilbao, Spain, 6Respiratory, Jimenez Diaz Hospital, Madrid, Spain, 7Otorhinolaryngology, Burgos University Hospital, Burgos, Spain, 8Respiratory, Valladolid University Hospital, Valladolid, Spain, 9Respiratory, Complejo Hospitalario de Cáceres, Cáceres, Spain, 10Sleep Unit, Marqueés de Valdecilla University Hospital, Cantabria, Spain, 11Respiratory, La Paz University Hospital, Madrid, Spain, 12Rio Ortega University Hospital, Valladolid, Spain, 13Department of Pediatrics, The University of Chicago, Chicago, IL, United States, 14Respiratory, 12 de Octubre University Hospital, Madrid, Spain.
INTRODUCTION: Obstructive sleep apnea (OSA) in children is a highly prevalent condition associated with morbidities. However, most of children with OSA remain undiagnosed. Diagnosis requires conventional polysomnography (PSG). PSG is time-consuming, inconvenient, and expensive, which generates a diagnostic accessibility problem. Home respiratory polygraphy (HRP) has been proposed to reduce costs and facilitate the diagnostic process. However, evidence supporting its validity is still scarce.
OBJECTIVES:
PRIMARY: To establish the diagnostic and therapeutic decision validity of HRP compared to the findings obtained with PSG in the sleep laboratory in children with clinically suspected OSA.
SECONDARY: a) Analyze the cost-effectiveness of the HRP versus PSG. b) Evaluate the impact of therapeutic interventions based on HRP results when compared with PSG findings at six months after treatment using sleep, health, and quality of life questionnaires. c) Analyze the validity of the determination of a series of proteins in urine, alone or in combination, to establish the diagnosis of OSA and to evaluate its modification after the treatment. d) Analyze the cost-effectiveness of HRP vs. PSG in the treatment of OSA.
METHODOLOGY: a) Design: Randomized, prospective, multicenter, double blind and crossover trial. The study will include 320 children (ages 2-14 years), both sexes, with clinical suspicion of OSA. b) Measurements: All participants will be evaluated for: clinical history; anthropometric variables: weight, height, body mass index, neck circumference and percentile; Chervin questionnaire, quality of life and clinical questionnaires and comorbidity; PSG in the sleep laboratory at the beginning of the study and its repetition after six month of treatment; HRP at home; Quantitative unbiased proteomic urine analysis and Cost-effectiveness variables.
ANALYSIS: Data from HRP and from full PSG will be compared as follows: 1) Agreement of results according to the different apnea-hypopnea index by using ROC and Bland-Altman analyses; 2) The concordance of the diagnosis and treatment decisions when using clinical findings and data from PSG or HRP at home, 3) All data will be analyzed independently by participating hospitals according the Cohen Kappa method, 4) A diagnostic paradigm based
on proteomic defined variables and 5) A cost-effectiveness analysis of the different diagnostic and therapeutic procedures.
INTEREST OF THE STUDY: The main interest of this study is: a) It constitutes the biggest study on HRP validation carried out to date. b) Is a multicenter study that includes eleven university hospitals in Spain. 3) A cost-effectiveness analysis is made for both diagnosis and treatment decisions.