Back to resultsEffect of CPAP (Continuous Positive Airway Pressure) on Lung Function in Asthmatics With Sleep Apnea
Primary Purpose
Asthma, Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP machine as a result of sleep study
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Sleep Apnea, Obesity, CPAP
Eligibility Criteria
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.
Sites / Locations
- National Jewish Medical and Research Center
Outcomes
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
Full Information
NCT ID
NCT00238069
First Posted
October 11, 2005
Last Updated
March 27, 2017
Sponsor
National Jewish Health
1. Study Identification
Unique Protocol Identification Number
NCT00238069
Brief Title
Effect of CPAP (Continuous Positive Airway Pressure) on Lung Function in Asthmatics With Sleep Apnea
Official Title
Effect of CPAP (Continuous Positive Airway Pressure) on Airway Inflammation in Asthmatics With Sleep-Disordered Breathing: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Jewish Health
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Sleep Apnea
Keywords
Asthma, Sleep Apnea, Obesity, CPAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CPAP machine as a result of sleep study
Primary Outcome Measure Information:
Title
Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.
Title
Exhaled breath condensate levels of IL-6 and 8-isporostane will be measured.
Title
BAL (bronchial lavage) fluid cell count and differential, IL-6, IL-8, and TNF- α will be measured.
Title
Endobronchial biopsies to analyze extent and type of inflammatory cell.
Secondary Outcome Measure Information:
Title
Symptoms, albuterol use and daily morning and evening peak expiratory flows from diary cards.
Title
Spirometry measured at three time points: before, during, and after CPAP therapy.
Title
Post-CPAP methacholine for bronchial hyperreactivity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Martin, MD
Organizational Affiliation
National Jewish Medical and Research Center faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.nationaljewish.org/professionals/research/programs-depts/felt-lab
Description
clinical lab website within National Jewish Medical and Research Center
Learn more about this trial
Effect of CPAP (Continuous Positive Airway Pressure) on Lung Function in Asthmatics With Sleep Apnea
We'll reach out to this number within 24 hrs