Idiopathic Pulmonary Fibrosis, Obstructive Sleep Apnea, Gastro Esophageal Reflux
Conditions
Keywords
IPF, OSA, GERD
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPositive Airway Pressure
Gentle and steady pressure (with or without supplemental oxygen) delivered to the airways of the lungs while subjects are sleeping.
Sponsors
University of Arizona
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* confirmed diagnosis of IPF based on the 2018 IPF guidelines * high likelihood of OSA based on the STOP-BANG measure, with a score of 3 or greater * patients on nintedanib, or in whom nintedanib will be initiated prior to enrollment in the study * able to participated in 24hr pH monitoring * able to comply with CPAP treatment * able to provide written informed consent prior to any study procedures * willing to complete all study measurements and assessments in compliance with the protocol
Exclusion criteria
* interstitial lung disease caused by conditions other than IPF * severe concomitant illness limiting life expectancy (\< 1 year) * residual lung volume \> or equal to 120% of predicted * obstructive lung disease: FEV1/FVC ratio \< 0.70 * current drug or alcohol dependence * patients who are unable to tolerate nintedanib * patients who are unable to use CPAP or are unwilling to participate in the 24 hr pH probe placement * patients who were diagnosed with recent IPF exacerbation within 4 weeks of enrollment (may be rescheduled for enrollment once recovered) * patients who have had prior nasal surgery or trauma that would make pH probe placement difficult * patients on anticoagulation (aspirin is not an exclusion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Biomarker Score | 4-8 weeks | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker of Lung Inflammation: KL-6 | 4-8 weeks | The value of KL-6 measured by ELISA in U/ml. |
| Biomarker of Lung Inflammation: MMP1 | 4-8 weeks | The value of MMP1 measured by ELISA in ng/ml. |
| Biomarker of Lung Inflammation: MMP7 | 4-8 weeks | The value of MMP7 measured by ELISA in ng/ml. |
| Biomarker of Lung Inflammation: IL-8 | 4-8 weeks | The value of IL-8 measured by ELISA in pg/ml. |
| Biomarker of Lung Inflammation: CXCL13 | 4-8 weeks | The value of CXCL-13 measured by ELISA in pg/ml. |
| Esophageal pH During Sleep | 4-8 weeks | Total sleep time (in minutes) with pH less than 4. |
| 24hr-Esophageal pH | 4-8 weeks | Total time (minutes in 24hr period) with pH less than 4. |
| FVC change | 6 months | FVC change in percentage of predicted values over 6 months (baseline to 6 months). |
| Composite Biomarker Score at Six Months | 6 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.) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSachin Chaudhary, MD
University of Arizona
Outcome results
None listed