Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

Official title: Exercised-Induced Bronchoconstriction in Patients With Severe Obstructive Sleep Apnea

Status Recruiting

Clinical Trial Summary

Purposes:

1. To investigate whether patients with severe obstructive sleep apnea syndrome (OSAS) are at higher risk for exercised-induced bronchoconstriction (EIB) due to baseline airway inflammation compared with age, gender, and body mass index (BMI)-matched controls.

2. To investigate the effect of 3-month continuous positive airway pressure (CPAP) therapy on EIB for patients with severe OSAS.

Clinical Trial Description

Obstructive sleep apnea syndrome (OSAS) is characterized by repeated episodes of upper airway obstruction during sleep. Recent studies have found evidence of airway inflammation in patients with OSAS. Individuals with chronic airway inflammation are at higher risk for exercise-induced bronchoconstriction (EIB). We hypothesized patients with OSAS are at higher risk for EIB due to baseline airway inflammation. Continuous positive airway pressure (CPAP) is a known standard treatment for OSAS, thus the second aim of the study will be investigating the effect of 3-month CPAP therapy on EIB for patients with OSAS. Twenty severe OSAS patients and 20 control individuals matched for age, gender, and body mass index (BMI) will be recruited. All participants will come to the laboratory on 2 separate days (5~14 days interval). On the 1st visit, baseline pulmonary function test (PFT) and airway inflammation assess by induced sputum will be performed. On the 2nd visit, an exercise challenge test will be performed using standard testing protocol and post-exercise forced expiratory volume in one second (FEV1) will be measured at 2.5, 5, 10, 15,20, and 30 minutes. For patients with severe OSAS, all measurements will be repeated after 3-month CPAP therapy. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Asthma, Exercise-Induced
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT00916773
• Study type: Interventional
• Source: National Taiwan University Hospital
• Contact: Liying Wang
• Phone: 886-3366-8123
• Email: ptschool@ntu.edu.tw
• Status: Recruiting
• Phase: N/A
• Start date: April 2009
• Completion date: April 2010