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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00780923
First Posted: October 28, 2008
Last Update Posted: March 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
  Purpose
The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic inflammation in obstructive sleep apnea.

Condition Intervention
Obstructive Sleep Apnea Inflammation Continuous Positive Airway Pressure Device: CPAP treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Longitudinal Study of Short-Term Effects of CPAP Treatment on Airway and Systemic Inflammation in Patients With Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Toru Oga, Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum. [ Time Frame: 3 months ]

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

Enrollment: 43
Study Start Date: January 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPAP Device: CPAP treatment
maintains upper airway patency and minimizes the obstructive events
Other Name: REMstar(Respironics), SleepMate(ResMed)

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780923


Locations
Japan
Kyoto University Graduate School of Medicine
Kyoto, Japan, 6068507
Sponsors and Collaborators
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
  More Information

Responsible Party: Toru Oga, Associate Professor, Respiratory Care and Sleep Control Medicine, Kyoto University Graduate School of Medicine, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00780923     History of Changes
Other Study ID Numbers: E-558
First Submitted: October 27, 2008
First Posted: October 28, 2008
Last Update Posted: March 27, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Inflammation
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases