Sleep Apnea, ObstructiveNCT00916773
Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea
A study testing continuous positive airway pressure (CPAP) in people with Sleep Apnea, Obstructive and Asthma, Exercise-Induced, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Asthma, Exercise-Induced
- What is being tested?
- continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ranged 18-65 y/o
- Severe OSA (AHI≧30/hr)
- BMI<35 kg/m2
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Liying Wang, Ph.D., +886-2-33668142, liying@ntu.edu.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive, Asthma, Exercise-Induced
- Being tested
- continuous positive airway pressure (CPAP)
- Keywords
- Obstructive sleep apnea, Airway inflammation, Exercise-induced bronchoconstriction, Continuous positive airway pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressure (CPAP)Device
CPAP of optimal pressure used during sleep for 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of changed forced expiratory volume in 1 second. (to determine if an exercise-induced bronchoconstriction attacked)
Measured: 3 month
Secondary outcomes (1)
Percentage of different inflammatory cells in induced sputum. (to determine to severity of baseline airway inflammation)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Liying Wang, Ph.D., Principal investigator, School and Graduate Institute of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916773
- Sponsor's protocol ID
- 200712118R
- Status last verified
- Jun 2009
- First submitted
- 8 Jun 2009
- Last updated
- 10 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercised-Induced Bronchoconstriction in Patients With Severe Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00916773
- Acronym / sponsor ID
- 200712118R
- Conditions
- Sleep Apnea, Obstructive, Asthma, Exercise-Induced
- Keywords
- Obstructive sleep apnea, Airway inflammation, Exercise-induced bronchoconstriction, Continuous positive airway pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ranged 18-65 y/o
- Severe OSA (AHI≧30/hr)
- BMI<35 kg/m2
Key exclusion criteria (10 listed)
- Clinical asthma
- Chronic lung disease (FEV1<70% predicted or FEV1/FVC<70%)
- Exercise contraindication:
- Respiratory tract infection in the past 2 weeks
- Inability to perform acceptable-quality spirometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous positive airway pressure (CPAP)CPAP of optimal pressure used during sleep for 3 months | Device | – |
Primary outcome
Percentage of changed forced expiratory volume in 1 second. (to determine if an exercise-induced bronchoconstriction attacked)
Time frame: 3 month
1 secondary outcome
Percentage of different inflammatory cells in induced sputum. (to determine to severity of baseline airway inflammation)
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liying Wang, Ph.D. principal investigator
School and Graduate Institute of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure (CPAP) in people with Sleep Apnea, Obstructive and Asthma, Exercise-Induced, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liying Wang (886-3366-8123, ptschool@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of changed forced expiratory volume in 1 second. (to determine if an exercise-induced bronchoconstriction attacked) (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2009; AzTrials last refreshed its copy on 1 Nov 2026.