Effect of Continuous Positive Airway Pressure Treatment on Inflammation in Patients With Obstructive Sleep Apnea

March 25, 2013 updated by: Toru Oga, Kyoto University, Graduate School of Medicine

A Longitudinal Study of Short-Term Effects of CPAP Treatment on Airway and Systemic Inflammation in Patients With Obstructive Sleep Apnea

The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic inflammation in obstructive sleep apnea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obstructive sleep apnea (OSA) is characterised by repetitive episodes of upper airway obstruction during sleep. Systemic and airway inflammation has been recently shown to be associated with OSA and is hypothesized to contribute to the clinical manifestation and the complications of OSA patients.

Continuous positive airway pressure (CPAP) is a first-line treatment for OSA and improves diurnal and nocturnal symptoms. However, the effectiveness of CPAP in reversing airway inflammation is less compelling in comparison to systemic inflammation.

This study will assess NO in exhaled breath, inflammatory biomarkers in induced sputum and blood of OSA patients and other clinical measurements before and after 3 months of CPAP treatment.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 6068507
        • Kyoto University Graduate School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
  • Subjects diagnosed with OSA (apnea hypopnea index >=20/hour) by overnight polysomnography.

Exclusion Criteria:

  • Known history of respiratory diseases that will affect airway inflammatory markers like asthma, chronic obstructive pulmonary disease and bronchiectasis.
  • Treatments with corticosteroids or other immunosuppressive drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP
Device: CPAP treatment
maintains upper airway patency and minimizes the obstructive events
Other Names:
  • REMstar(Respironics), SleepMate(ResMed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: 3 months
3 months
Sleep quality
Time Frame: 3 months
3 months
NO in exhaled breath
Time Frame: 3 months
3 months
Airway resistance
Time Frame: 3 months
3 months
PSG measurement(AHI,etc.)
Time Frame: 3 months
3 months
Psychological status
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University, Graduate School of Medicine

Investigators

  • Principal Investigator: Kazuo Chin, MD,PhD, Kyoto University, Graduate School of Medicine
  • Principal Investigator: Toru Oga, MD,PhD, Kyoto University, Graduate School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 27, 2008

First Submitted That Met QC Criteria

October 27, 2008

First Posted (Estimate)

October 28, 2008

Study Record Updates

Last Update Posted (Estimate)

March 27, 2013

Last Update Submitted That Met QC Criteria

March 25, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-558

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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