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Completed

NCT Number: NCT00780923

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

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Continuous Positive Airway Pressure Dyssomnias Inflammation Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyoto University Graduate School of Medicine

Kyoto, 6068507, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP Treatment

Device

maintains upper airway patency and minimizes the obstructive events

Other names: REMstar(Respironics), SleepMate(ResMed)

Primary outcomes

  1. Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum.

    Time frame: 3 months

Secondary outcomes

  1. NO in exhaled breath

    Time frame: 3 months

  2. Airway resistance

    Time frame: 3 months

  3. PSG measurement(AHI,etc.)

    Time frame: 3 months

  4. Quality of Life

    Time frame: 3 months

  5. Psychological status

    Time frame: 3 months

  6. Sleep quality

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Kyoto University, Graduate School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2008
Registry last updated
Mar 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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