NCT00916773

Brief Summary

Purposes:

  1. 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. 2.To investigate the effect of 3-month continuous positive airway pressure (CPAP) therapy on EIB for patients with severe OSAS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 10, 2009

Status Verified

June 1, 2009

Enrollment Period

1 year

First QC Date

June 8, 2009

Last Update Submit

June 9, 2009

Conditions

Sleep Apnea, ObstructiveAsthma, Exercise-Induced

Keywords

Obstructive sleep apneaAirway inflammationExercise-induced bronchoconstrictionContinuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

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

    3 month

Secondary Outcomes (1)

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

    3 month

Interventions

continuous positive airway pressure (CPAP)DEVICE

CPAP of optimal pressure used during sleep for 3 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ranged 18-65 y/o
  • Severe OSA (AHI≧30/hr)
  • BMI\<35 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveAsthma, Exercise-Induced

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesAsthmaBronchial DiseasesRespiratory HypersensitivityExercise-Induced AllergiesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Liying Wang, Ph.D.

    School and Graduate Institute of Physical Therapy, National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liying Wang

CONTACT

886-3366-8123ptschool@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 10, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 10, 2009

Record last verified: 2009-06

Locations

TW(1)