Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea

Not Applicable

• Conditions: Sleep Apnea, Obstructive; Asthma, Exercise-Induced

• Registration Number: NCT00916773
• Lead Sponsor: National Taiwan University Hospital

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 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 Timeline

• Study Start: 2009-04
• Status Verified: 2009-06
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-09
• Last Update Submitted: 2009-06-09
• Study First Posted: 2009-06-10
• Last Update Posted: 2009-06-10
• Primary Completion: 2010-04
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age ranged 18-65 y/o
2. Severe OSA (AHI≧30/hr)
3. BMI<35 kg/m2

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Exclusion Criteria

1. Clinical asthma

2. Chronic lung disease (FEV1<70% predicted or FEV1/FVC<70%)

3. Exercise contraindication:

   • Stroke or heart attack in last 3 months
   • Major cardiovascular disease
   • Unstable angina
   • Unable to perform cycle ergometry due to musculoskeletal problems

4. Respiratory tract infection in the past 2 weeks

5. Inability to perform acceptable-quality spirometry

6. Refuse to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of changed forced expiratory volume in 1 second. (to determine if an exercise-induced bronchoconstriction attacked)	3 month

Secondary Outcome Measures

Name	Time	Method
Percentage of different inflammatory cells in induced sputum. (to determine to severity of baseline airway inflammation)	3 month

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan