ClinicalTrials.gg
Status unknownNCT00916773Updated Jun 10, 2009

Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea

An interventional study of continuous positive airway pressure (CPAP) in Sleep Apnea, Obstructive and Asthma, Exercise-Induced, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-06-10.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sleep Apnea, Obstructive
  • Asthma, Exercise-Induced

Keywords

  • Obstructive sleep apnea
  • Airway inflammation
  • Exercise-induced bronchoconstriction
  • Continuous positive airway pressure
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 100 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ranged 18-65 y/o
  2. Severe OSA (AHI≧30/hr)
  3. \<35 kg/m2

Exclusion criteria

Exclusion Criteria:

  1. Clinical asthma
  2. Chronic lung disease (\<70% predicted or FEV1/FVC\<70%)
  3. Exercise :

    • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Interventions

  • Devicecontinuous positive airway pressure (CPAP)

    CPAP of optimal pressure used during sleep for 3 months

06

What researchers measure

Primary outcomes

  1. Percentage of changed forced expiratory volume in 1 second. (to determine if an exercise-induced bronchoconstriction attacked)

    Time frame: 3 month

Secondary outcomes

  1. Percentage of different inflammatory cells in induced sputum. (to determine to severity of baseline airway inflammation)

    Time frame: 3 month

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00916773
First posted
Jun 10, 2009
Start date
Apr 2009
Primary completion
Apr 2010 (estimated)
Completion
Apr 2010 (estimated)
Last update
Jun 10, 2009

Study contacts

Liying Wang
Contact
ptschool@ntu.edu.tw
886-3366-8123
Liying Wang, Ph.D.
principal investigator · School and Graduate Institute of Physical Therapy, National Taiwan University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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