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Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00916773
First received: June 8, 2009
Last updated: June 9, 2009
Last verified: June 2009
  Purpose

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.

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercised-Induced Bronchoconstriction in Patients With Severe Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Percentage of changed forced expiratory volume in 1 second. (to determine if an exercise-induced bronchoconstriction attacked) [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of different inflammatory cells in induced sputum. (to determine to severity of baseline airway inflammation) [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: continuous positive airway pressure (CPAP)
    CPAP of optimal pressure used during sleep for 3 months
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916773

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

Locations
Taiwan
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
Investigators
Principal Investigator: Liying Wang, Ph.D. School and Graduate Institute of Physical Therapy, National Taiwan University
  More Information

No publications provided

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
Study First Received: June 8, 2009
Last Updated: June 9, 2009
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on November 25, 2014