- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00916773
Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea
June 9, 2009 updated by: National Taiwan University Hospital
Exercised-Induced Bronchoconstriction in Patients With Severe Obstructive Sleep Apnea
Purposes:
- 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.
- To investigate the effect of 3-month continuous positive airway pressure (CPAP) therapy on EIB for patients with severe OSAS.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liying Wang
- Phone Number: 886-3366-8123
- Email: ptschool@ntu.edu.tw
Study Locations
-
-
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Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Liying Wang, Ph.D.
- Phone Number: +886-2-33668142
- Email: liying@ntu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ranged 18-65 y/o
- Severe OSA (AHI≧30/hr)
- BMI<35 kg/m2
Exclusion Criteria:
- Clinical asthma
- Chronic lung disease (FEV1<70% predicted or FEV1/FVC<70%)
Exercise contraindication:
- Stroke or heart attack in last 3 months
- Major cardiovascular disease
- Unstable angina
- Unable to perform cycle ergometry due to musculoskeletal problems
- Respiratory tract infection in the past 2 weeks
- Inability to perform acceptable-quality spirometry
- Refuse to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of changed forced expiratory volume in 1 second. (to determine if an exercise-induced bronchoconstriction attacked)
Time Frame: 3 month
|
3 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of different inflammatory cells in induced sputum. (to determine to severity of baseline airway inflammation)
Time Frame: 3 month
|
3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Liying Wang, Ph.D., School and Graduate Institute of Physical Therapy, National Taiwan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Anticipated)
April 1, 2010
Study Completion (Anticipated)
April 1, 2010
Study Registration Dates
First Submitted
June 8, 2009
First Submitted That Met QC Criteria
June 9, 2009
First Posted (Estimate)
June 10, 2009
Study Record Updates
Last Update Posted (Estimate)
June 10, 2009
Last Update Submitted That Met QC Criteria
June 9, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Hypersensitivity, Immediate
- Bronchial Diseases
- Signs and Symptoms, Respiratory
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Asthma, Exercise-Induced
Other Study ID Numbers
- 200712118R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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