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

This study has been completed.
Information provided by:
National Jewish Health Identifier:
First received: October 11, 2005
Last updated: March 27, 2017
Last verified: March 2017
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.

Condition Intervention
Asthma Sleep Apnea Device: CPAP machine as a result of sleep study

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of CPAP (Continuous Positive Airway Pressure) on Airway Inflammation in Asthmatics With Sleep-Disordered Breathing: A Pilot Study

Resource links provided by NLM:

Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.
  • Exhaled breath condensate levels of IL-6 and 8-isporostane will be measured.
  • BAL (bronchial lavage) fluid cell count and differential, IL-6, IL-8, and TNF- α will be measured.
  • Endobronchial biopsies to analyze extent and type of inflammatory cell.

Secondary Outcome Measures:
  • Symptoms, albuterol use and daily morning and evening peak expiratory flows from diary cards.
  • Spirometry measured at three time points: before, during, and after CPAP therapy.
  • Post-CPAP methacholine for bronchial hyperreactivity

Enrollment: 20
Study Start Date: December 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00238069

United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Principal Investigator: Richard Martin, MD National Jewish Medical and Research Center faculty
  More Information

Additional Information: Identifier: NCT00238069     History of Changes
Other Study ID Numbers: HS-1866
Study First Received: October 11, 2005
Last Updated: March 27, 2017

Keywords provided by National Jewish Health:
Sleep Apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on September 21, 2017