Study of the effect of negative expiratory pressure method generated in the mouth in bus drivers professionals subjects with suspect of obstructive sleep apnea.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-7dq5xx
• Date of registration: 11/07/2011
• Primary sponsor: Universidade Nove de Julho - UNINOVE - Brazil
• Public title: Study of the effect of negative expiratory pressure method generated in the mouth in bus drivers professionals subjects with suspect of obstructive sleep apnea.
• Scientific title: Cross-sectional study on efficacy of negative expiratory pressure test proposed as screening for obstructive sleep apnea syndrome among commercial interstate bus drivers
• Target sample size: 82
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7dq5xx/
• Study design: An observational, analytical, cross-sectional single arm diagnostic study, blind.

Countries of recruitment

Brazil

Contacts

• Name: Luis Vicente Oliveira
• Affiliation: Universidade Nove de Julho - UNINOVE

• Name: Luis Vicente Oliveira
• Affiliation: Universidade Nove de Julho - UNINOVE

Key inclusion & exclusion criteria

Inclusion criteria: Male interstate professional bus drivers who agree to sign the Informed Consent Term.
Exclusion criteria: Subjects with ischemic and dilated heart disease;
Subjects with episodes of acute decompensation in the two months prior to the study protocol;
Subjects with primary heart valve disease;
or acute or chronic cardiopulmonary or neuromuscular diseases;
Subjects who have been submitted to recent surgical procedures in the region of the chest wall; or those with a history of stroke, drug users and those who abuse alcohol.


Age minimum: 22Y
Age maximum: 65Y
Gender: M

Health Condition(s) or Problem(s) studied

Tests will be performed to verify that a negative expiratory pressure equipment has a sensitivity and specificity for identifying the presence of obstructive sleep apnea which is characterized as a sleep disorder in professional bus drivers subjects.
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Intervention(s)

All will be asked to participate in the study and all procedures will be clarified. There will be no control group, because it is a cross sectional observational study of screening. Those who agree to participate will undergo a medical exam with a detailed patient history, physical exam involving determination of blood pressure, anthropometric data, circumference measurements (hips, abdomen and neck), Mallampati index and tonsil index. Moreover, specific questionnaires addressing sleep apnea and excessive daytime sleepiness will be administered. Data acquisition will be completely anonymous. Following the medical exam, the participants will be submitted to a lung function test (spirometry), NEP test and standard overnight polysomnography.

Primary Outcome(s)

Primary outcome 1: [Expiratory flow limitation as flow drop (V`), expressed as the percentage of expiratory peak flow immediately after negative expiratory pressure application.
Timepoint: This will be measured after the clinical and demographic collecting data and after the obstruction diagnosis by spirometry is discarded.

Primary outcome 2: [Volume expired in 0.2s (V0.2s) immediately after negative expiratory pressure administration]
Timepoint: This will be measured after the clinical and demographic collecting data and after the obstruction diagnosis by spirometry is discarded.

Primary outcome 3: Apnea/hypopnea index (AHI). (Apnea was defined as complete cessation of airflow for > 10 seconds, associated with oxygen desaturation of 3%. Hypopnea was defined as a significant reduction (>50%) in respiratory signals for > 10 seconds associated with oxygen desaturation of 4%. The AHI was calculated as the total number of respiratory events (apneas plus hypopneas) per hour of sleep through standart overnight polysomnography.
Timepoint: This will be measured after the clinical and demographic collecting data, by the standard overnight polysomnography.

Secondary Outcome(s)

Secondary outcome 1: [High/low risk at Berlin Questionnaire which is a 10-item questionnaire with recognized efficacy in distinguishing subjects at greater risk for OSA]
Timepoint: This will be measured after the clinical and demographic collecting data.

Secondary outcome 10: [Time with peripherical oxyhemoglobin saturation - SpO2 < 90%, as assessed by the standart overnight polysomnography].
Timepoint: This will be measured after the clinical and demographic collecting data, by the standard overnight polysomnography.

Secondary outcome 2: [Score at the Epworth Scale, which is used for the assessment of excessive daytime sleepiness]
Timepoint: This will be measured after the clinical and demographic collecting data.

Secondary outcome 3: [Waist circumference as assessed at physical exam].
Timepoint: At the physical exam.

Secondary outcome 4: [Neck circumference as assessed at physical exam].
Timepoint: At the physical exam.

Secondary outcome 5: [Mallampati index (I – IV score) as assessed with the patient with the mouth wide opened and voluntary protrusion of the tongue without phonation].
Timepoint: At the physical exam.

Secondary outcome 6: [Work experience which is the time working as a professional driver].
Timepoint: At the medical exam.

Secondary outcome 7: [all items composing the criteria for clinical diagnostic of Metabolic Syndrome (elevated waist circumference, elevated tryglicerides, reduced high-density lipoprotein cholesterol – HDL-C, elevated blood pressure and elevated fasting glucose) as assessed by data linkage to medical records].
Timepoint: at first time, before initiating the protocol study.

Secondary outcome 8: [body mass index – BMI, as assessed by data linkage to medical records].
Timepoint: at first time, before initiating the protocol study.

Secondary outcome 9: [Sleep efficiency, as assessed by the standart overnight polysomnography].
Timepoint: This will be measured after the clinical and demographic collecting data, by the standard overnight polysomnography.

Secondary ID(s)

307618/2010-2

329445/2010

Source(s) of Monetary Support

Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (local acronym CNPq) - Brazil