This study will evaluate the effect of CPAP therapy on esophageal pH and lung inflammation in patients with idiopathic pulmonary fibrosis (IPF) and sleep apnea.
Participants in this study will have an overnight sleep study done while wearing a 24 hour pH monitor in the esophagus. If the participant has sleep apnea, he or she will be randomly assigned to receive either CPAP treatment or no CPAP treatment. After 4-8 weeks, the participant will have another overnight sleep study with 24 hour pH monitoring. Blood will also be collected at both time points and again after 6 months to measure biomarkers that are related to lung inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Gentle and steady pressure (with or without supplemental oxygen) delivered to the airways of the lungs while subjects are sleeping.
University of Arizona
Tucson, Arizona, United States
Composite Biomarker Score
The primary outcome will be a composite value that is a weighted average of z-scores of the biomarkers MMP1, MMP7, IL-8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker. MMP1, MMP7, IL-8, KL-6, and CXCL13 will be measured using enzyme linked immunosorbent assays (ELISA) for these analytes. (Z-score is a unitless number, as is the weighted average.)
Time frame: 4-8 weeks
Biomarker of Lung Inflammation: KL-6
The value of KL-6 measured by ELISA in U/ml.
Time frame: 4-8 weeks
Biomarker of Lung Inflammation: MMP1
The value of MMP1 measured by ELISA in ng/ml.
Time frame: 4-8 weeks
Biomarker of Lung Inflammation: MMP7
The value of MMP7 measured by ELISA in ng/ml.
Time frame: 4-8 weeks
Biomarker of Lung Inflammation: IL-8
The value of IL-8 measured by ELISA in pg/ml.
Time frame: 4-8 weeks
Biomarker of Lung Inflammation: CXCL13
The value of CXCL-13 measured by ELISA in pg/ml.
Time frame: 4-8 weeks
Esophageal pH During Sleep
Total sleep time (in minutes) with pH less than 4.
Time frame: 4-8 weeks
24hr-Esophageal pH
Total time (minutes in 24hr period) with pH less than 4.
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Time frame: 4-8 weeks
FVC change
FVC change in percentage of predicted values over 6 months (baseline to 6 months).
Time frame: 6 months
Composite Biomarker Score at Six Months
Weighted average of z-scores of the biomarkers MMP1, MMP7, IL8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker at six months. (Z-score is a unitless number, as is the weighted average.)
Time frame: 6 months