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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP | Experimental | Subjects randomized to the treatment arm, will receive continuous positive airway pressure (CPAP) while sleeping via an autoPAP device for 4-8 weeks. |
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| No CPAP | No Intervention | Subjects assigned to the no CPAP group will not have any intervention for a 4-8 week period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Airway Pressure | Device | Gentle and steady pressure (with or without supplemental oxygen) delivered to the airways of the lungs while subjects are sleeping. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.) | 4-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker of Lung Inflammation: KL-6 | The value of KL-6 measured by ELISA in U/ml. | 4-8 weeks |
| Biomarker of Lung Inflammation: MMP1 | The value of MMP1 measured by ELISA in ng/ml. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sachin Chaudhary, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D020181 | Sleep Apnea, Obstructive |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Subjects will be assigned to treatment groups using a 1:1 randomized block design via the randomization module in REDCap. The PI and study coordinator will be blinded to next assignment.
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Study investigators and care providers will be blinded and not involved in any CPAP or no CPAP related set-up, instruction, or device troubleshooting during the course the treatment phase. Lab personnel performing biomarker analysis will only have access to subject study ID and not treatment group assignments.
| 4-8 weeks |
| Biomarker of Lung Inflammation: MMP7 | The value of MMP7 measured by ELISA in ng/ml. | 4-8 weeks |
| Biomarker of Lung Inflammation: IL-8 | The value of IL-8 measured by ELISA in pg/ml. | 4-8 weeks |
| Biomarker of Lung Inflammation: CXCL13 | The value of CXCL-13 measured by ELISA in pg/ml. | 4-8 weeks |
| Esophageal pH During Sleep | Total sleep time (in minutes) with pH less than 4. | 4-8 weeks |
| 24hr-Esophageal pH | Total time (minutes in 24hr period) with pH less than 4. | 4-8 weeks |
| FVC change | FVC change in percentage of predicted values over 6 months (baseline to 6 months). | 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.) | 6 months |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |