Pulmonary Disorders During Exercise in Patients With Obstructive Sleep Apnea

NCT ID: NCT00916773

Last Updated: 2009-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-04-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

continuous positive airway pressure (CPAP)

CPAP of optimal pressure used during sleep for 3 months

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

School and Graduate Institute of Physical Therapy, National Taiwan University

Principal Investigators

Liying Wang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

School and Graduate Institute of Physical Therapy, National Taiwan University

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Liying Wang

Role: CONTACT

ptschool@ntu.edu.tw

886-3366-8123

Facility Contacts

Liying Wang, Ph.D.

Role: primary

liying@ntu.edu.tw

+886-2-33668142

Other Identifiers

200712118R

Identifier Type: -

Identifier Source: org_study_id