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

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

Detailed Description
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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.

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

Conditions
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Obstructive Sleep Apnea, Inflammation, Continuous Positive Airway Pressure

Intervention / Treatment
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* Device: CPAP treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP<br> | Device: CPAP treatment<br>* maintains upper airway patency and minimizes the obstructive events<br>* Other names: REMstar(Respironics), SleepMate(ResMed);|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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