Effect of CPAP on Abnormal Gastroesophageal Reflux and Lung Inflammation in IPF
Purpose
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.
Conditions
- Idiopathic Pulmonary Fibrosis
- Obstructive Sleep Apnea
- Gastro Esophageal Reflux
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Genders
- All
- Accepts 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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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.
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CPAP |
Subjects randomized to the treatment arm, will receive continuous positive airway pressure (CPAP) while sleeping via an autoPAP device for 4-8 weeks. |
|
|
No Intervention No CPAP |
Subjects assigned to the no CPAP group will not have any intervention for a 4-8 week period. |
|
Recruiting Locations
University of Arizona
Tucson, Arizona 85724
Tucson, Arizona 85724
More Details
- NCT ID
- NCT05359965
- Status
- Recruiting
- Sponsor
- University of Arizona
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.