Asthma, Sleep Apnea
Conditions
Keywords
Asthma, Sleep Apnea, Obesity, CPAP
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.
Interventions
DEVICECPAP machine as a result of sleep study
Sponsors
National Jewish Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Spirometry measured at three time points: before, during, and after CPAP therapy. | — |
| Post-CPAP methacholine for bronchial hyperreactivity | — |
| Symptoms, albuterol use and daily morning and evening peak expiratory flows from diary cards. | — |
Countries
United States
Outcome results
None listed