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

NCT ID: NCT00780923

Last Updated: 2013-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-03-31

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.

Conditions

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Obstructive Sleep Apnea Inflammation Continuous Positive Airway Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP

Group Type EXPERIMENTAL

CPAP treatment

Intervention Type DEVICE

maintains upper airway patency and minimizes the obstructive events

Interventions

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CPAP treatment

maintains upper airway patency and minimizes the obstructive events

Intervention Type DEVICE

Other Intervention Names

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REMstar(Respironics), SleepMate(ResMed)

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyoto University, Graduate School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Toru Oga

Associate Professor, Respiratory Care and Sleep Control Medicine, Kyoto University Graduate School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kazuo Chin, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Kyoto University, Graduate School of Medicine

Toru Oga, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Kyoto University, Graduate School of Medicine

Locations

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Kyoto University Graduate School of Medicine

Kyoto, Kyoto, Japan

Site Status

Countries

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Japan

Other Identifiers

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E-558

Identifier Type: -

Identifier Source: org_study_id

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