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Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea

Exercised-Induced Bronchoconstriction in Patients With Severe Obstructive Sleep Apnea

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00916773
Enrollment
100
Registered
2009-06-10
Start date
2009-04-30
Completion date
2010-04-30
Last updated
2009-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Exercise-Induced, Sleep Apnea, Obstructive

Keywords

Obstructive sleep apnea, Airway inflammation, Exercise-induced bronchoconstriction, Continuous positive airway pressure

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.

Interventions

DEVICEcontinuous positive airway pressure (CPAP)

CPAP of optimal pressure used during sleep for 3 months

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Percentage of different inflammatory cells in induced sputum. (to determine to severity of baseline airway inflammation)3 month

Countries

Taiwan

Contacts

Primary ContactLiying Wang
ptschool@ntu.edu.tw886-3366-8123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026