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Open Access Study protocol

Observational study on efficacy of negative expiratory pressure test proposed as screening for obstructive sleep apnea syndrome among commercial interstate bus drivers - protocol study

Raquel P Hirata1, Isabella C Aguiar1, Sergio R Nacif2, Lilian C Giannasi3, Fernando SS Leitão Filho4, Israel R Santos1, Salvatore Romano5, Newton S Faria1, Paula N Nonaka1, Luciana MM Sampaio1, Claudia S Oliveira1, Paulo TC Carvalho1, Geraldo Lorenzi-Filho6, Alberto Braghiroli7, Adriana Salvaggio5, Giuseppe Insalaco5 and Luis VF Oliveira1*

Author Affiliations

1 Master's and Doctoral Degree Programs in Rehabilitation Sciences, Nove de Julho, University, Sao Paulo, Brazil

2 Pulmonary Division, Servidor Publico do Estado de Sao Paulo Hospital, Sao Paulo, Brazil

3 School of Dentistry, Julio Mesquita Filho State University, Sao Jose dos Campos, Brazil

4 Department of Medicine, Fortaleza University, Fortaleza, Brazil

5 National Research Council of Italy, Institute of Biomedicine and Molecular Immunology "A. Monroy", Palermo, Italy

6 Sleep Laboratory, Pulmonary Division, Heart Institute (InCor) Sao Paulo University, Medicine School, Sao Paulo, Brazil

7 Sleep Laboratory, Medical Center of Veruno, Salvatore Maugeri Foundation, Veruno (NO) Italy

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BMC Pulmonary Medicine 2011, 11:57  doi:10.1186/1471-2466-11-57

Published: 7 December 2011

Abstract

Background

Obstructive sleep apnea (OSA) is a respiratory disease characterized by the collapse of the extrathoracic airway and has important social implications related to accidents and cardiovascular risk. The main objective of the present study was to investigate whether the drop in expiratory flow and the volume expired in 0.2 s during the application of negative expiratory pressure (NEP) are associated with the presence and severity of OSA in a population of professional interstate bus drivers who travel medium and long distances.

Methods/Design

An observational, analytic study will be carried out involving adult male subjects of an interstate bus company. Those who agree to participate will undergo a detailed patient history, physical examination involving determination of blood pressure, anthropometric data, circumference measurements (hips, waist and neck), tonsils and Mallampati index. Moreover, specific questionnaires addressing sleep apnea and excessive daytime sleepiness will be administered. Data acquisition will be completely anonymous. Following the medical examination, the participants will perform a spirometry, NEP test and standard overnight polysomnography. The NEP test is performed through the administration of negative pressure at the mouth during expiration. This is a practical test performed while awake and requires little cooperation from the subject. In the absence of expiratory flow limitation, the increase in the pressure gradient between the alveoli and open upper airway caused by NEP results in an increase in expiratory flow.

Discussion

Despite the abundance of scientific evidence, OSA is still underdiagnosed in the general population. In addition, diagnostic procedures are expensive, and predictive criteria are still unsatisfactory. Because increased upper airway collapsibility is one of the main determinants of OSA, the response to the application of NEP could be a predictor of this disorder. With the enrollment of this study protocol, the expectation is to encounter predictive NEP values for different degrees of OSA in order to contribute toward an early diagnosis of this condition and reduce its impact and complications among commercial interstate bus drivers.

Registro Brasileiro de Ensaios Clinicos (local acronym RBEC) [Internet]: Rio de Janeiro (RJ): Instituto de Informaçao Cientifica e Tecnologica em Saude (Brazil); 2010 - Identifier RBR-7dq5xx. Cross-sectional study on efficacy of negative expiratory pressure test proposed as screening for obstructive sleep apnea syndrome among commercial interstate bus drivers; 2011 May 31 [7 pages]. Available from http://www.ensaiosclinicos.gov.br/rg/RBR-7dq5xx/ webcite.