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NCT Number: NCT00238069

Effect of CPAP (Continuous Positive Airway Pressure) on Lung Function in Asthmatics With Sleep Apnea

This is a research study of asthma and sleep apnea. Our hypothesis is that untreated sleep apnea causes inflammation in the lung, which can worsen asthma. We believe treatment of sleep apnea will reduce this inflammation, and improve asthma control. This study will help us better understand what happens to the lung and bronchial tubes before and after treatment of sleep apnea, which could benefit all patients with sleep apnea. This study involves 2 bronchoscopies.

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Key information

Conditions

Asthma Apnea Body Weight Bronchial Diseases Dyssomnias Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult (>18yrs at the time of recruitment)
  • Body mass index (BMI) ≥ 30
  • Symptoms suggestive of sleep apnea
  • Epworth Sleepiness Score (ESS) within range
  • Positive sleep study for sleep apnea

Exclusion criteria

  • Tobacco use within the last 3 months.
  • Presence of other significant comorbid heart or lung disease
  • Presence of another chronic inflammatory disease, such as connective-tissue disease, inflammatory bowel disease, or active infection.
  • Use of systemic steroids, as defined as any prednisone use in the preceding 3 months.
  • Use of leukotriene antagonists or theophylline within the preceding 6 weeks.
  • Presence of severe or uncontrolled sinusitis, such that CPAP therapy will be difficult or uncomfortable.
  • History of significant claustrophobia, uncontrolled psychiatric disease, or anticipated intolerance of CPAP therapy.
  • Night shift workers, or other subjects with significantly altered sleep-wake cycles.
  • Baseline post-bronchodilator FEV1 < 70% predicted.
  • Severe gastroesophageal reflux disease.

Treatment and study plan

CPAP machine as a result of sleep study

Device

Primary outcomes

  1. Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.

  2. Exhaled breath condensate levels of IL-6 and 8-isporostane will be measured.

  3. BAL (bronchial lavage) fluid cell count and differential, IL-6, IL-8, and TNF- α will be measured.

  4. Endobronchial biopsies to analyze extent and type of inflammatory cell.

Secondary outcomes

  1. Symptoms, albuterol use and daily morning and evening peak expiratory flows from diary cards.

  2. Spirometry measured at three time points: before, during, and after CPAP therapy.

  3. Post-CPAP methacholine for bronchial hyperreactivity

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Registry information

Official study title

Effect of CPAP (Continuous Positive Airway Pressure) on Airway Inflammation in Asthmatics With Sleep-Disordered Breathing: A Pilot Study

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 13, 2005
Registry last updated
Mar 29, 2017

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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