Clinical Trial: Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: National Taiwan University Hospital

Current Primary Outcome: Percentage of changed forced expiratory volume in 1 second. (to determine if an exercise-induced bronchoconstriction attacked) [ Time Frame: 3 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage of different inflammatory cells in induced sputum. (to determine to severity of baseline airway inflammation) [ Time Frame: 3 month ]

Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: June 8, 2009
Date Started: April 2009
Date Completion: April 2010
Last Updated: June 9, 2009
Last Verified: June 2009