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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT00780923
First received: October 27, 2008
Last updated: March 25, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 27, 2008
Last Updated: March 25, 2013
Health Authority: Japan: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014