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Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT00916773
Recruitment Status : Unknown
Verified June 2009 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 10, 2009
Last Update Posted : June 10, 2009
Information provided by:
National Taiwan University Hospital

Brief Summary:


  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.

Condition or disease Intervention/treatment
Sleep Apnea, Obstructive Asthma, Exercise-Induced Device: continuous positive airway pressure (CPAP)

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercised-Induced Bronchoconstriction in Patients With Severe Obstructive Sleep Apnea
Study Start Date : April 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: continuous positive airway pressure (CPAP)
    CPAP of optimal pressure used during sleep for 3 months

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916773

Contact: Liying Wang 886-3366-8123 ptschool@ntu.edu.tw

National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Liying Wang, Ph.D.    +886-2-33668142    liying@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Liying Wang, Ph.D. School and Graduate Institute of Physical Therapy, National Taiwan University

Responsible Party: Liying Wang, School and Graduate Institute of Physical Therapy, National Taiwan University
ClinicalTrials.gov Identifier: NCT00916773     History of Changes
Other Study ID Numbers: 200712118R
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: June 10, 2009
Last Verified: June 2009

Keywords provided by National Taiwan University Hospital:
Obstructive sleep apnea
Airway inflammation
Exercise-induced bronchoconstriction
Continuous positive airway pressure

Additional relevant MeSH terms:
Asthma, Exercise-Induced
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Bronchial Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases