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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Inflammation; Continuous Positive Airway Pressure
• Interventions: Device: CPAP treatment

• Registration Number: NCT00780923
• Lead Sponsor: Kyoto University, Graduate School of Medicine

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.

Study Timeline

• Study First Submitted: 2008-10-27
• Study First Submitted QC: 2008-10-27
• Study First Posted: 2008-10-28
• Study Start: 2009-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP	CPAP treatment	-

Primary Outcome Measures

Name	Time	Method
Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum.	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyoto University Graduate School of Medicine; 🇯🇵 Kyoto, Japan