Back to resultsEffect of Continuous Positive Airway Pressure Treatment on Inflammation in Patients With Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea, Inflammation, Continuous Positive Airway Pressure
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
CPAP treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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.
Sites / Locations
- Kyoto University Graduate School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CPAP
Arm Description
Outcomes
Primary Outcome Measures
Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum.
Secondary Outcome Measures
NO in exhaled breath
Airway resistance
PSG measurement(AHI,etc.)
Quality of Life
Psychological status
Sleep quality
Full Information
NCT ID
NCT00780923
First Posted
October 27, 2008
Last Updated
March 25, 2013
Sponsor
Kyoto University, Graduate School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00780923
Brief Title
Effect of Continuous Positive Airway Pressure Treatment on Inflammation in Patients With Obstructive Sleep Apnea
Official Title
A Longitudinal Study of Short-Term Effects of CPAP Treatment on Airway and Systemic Inflammation in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University, Graduate School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic inflammation in obstructive sleep apnea.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Inflammation, Continuous Positive Airway Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CPAP treatment
Other Intervention Name(s)
REMstar(Respironics), SleepMate(ResMed)
Intervention Description
maintains upper airway patency and minimizes the obstructive events
Primary Outcome Measure Information:
Title
Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
NO in exhaled breath
Time Frame
3 months
Title
Airway resistance
Time Frame
3 months
Title
PSG measurement(AHI,etc.)
Time Frame
3 months
Title
Quality of Life
Time Frame
3 months
Title
Psychological status
Time Frame
3 months
Title
Sleep quality
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuo Chin, MD,PhD
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Toru Oga, MD,PhD
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyoto University Graduate School of Medicine
City
Kyoto
ZIP/Postal Code
6068507
Country
Japan
12. IPD Sharing Statement
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Effect of Continuous Positive Airway Pressure Treatment on Inflammation in Patients With Obstructive Sleep Apnea
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