Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive, Asthma, Exercise-Induced
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
continuous positive airway pressure (CPAP)
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive sleep apnea, Airway inflammation, Exercise-induced bronchoconstriction, Continuous positive airway pressure
Eligibility Criteria
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
Sites / Locations
- National Taiwan University HospitalRecruiting
Outcomes
Primary Outcome Measures
Percentage of changed forced expiratory volume in 1 second. (to determine if an exercise-induced bronchoconstriction attacked)
Secondary Outcome Measures
Percentage of different inflammatory cells in induced sputum. (to determine to severity of baseline airway inflammation)
Full Information
NCT ID
NCT00916773
First Posted
June 8, 2009
Last Updated
June 9, 2009
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00916773
Brief Title
Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea
Official Title
Exercised-Induced Bronchoconstriction in Patients With Severe Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Asthma, Exercise-Induced
Keywords
Obstructive sleep apnea, Airway inflammation, Exercise-induced bronchoconstriction, Continuous positive airway pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
continuous positive airway pressure (CPAP)
Intervention Description
CPAP of optimal pressure used during sleep for 3 months
Primary Outcome Measure Information:
Title
Percentage of changed forced expiratory volume in 1 second. (to determine if an exercise-induced bronchoconstriction attacked)
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Percentage of different inflammatory cells in induced sputum. (to determine to severity of baseline airway inflammation)
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liying Wang
Phone
886-3366-8123
Email
ptschool@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liying Wang, Ph.D.
Organizational Affiliation
School and Graduate Institute of Physical Therapy, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liying Wang, Ph.D.
Phone
+886-2-33668142
Email
liying@ntu.edu.tw
12. IPD Sharing Statement
Learn more about this trial
Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea
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