Status:
ACTIVE_NOT_RECRUITING
Effect of CPAP on Abnormal Gastroesophageal Reflux and Lung Inflammation in IPF
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Idiopathic Pulmonary Fibrosis
Obstructive Sleep Apnea
Eligibility:
All Genders
50+ years
Phase:
NA
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 recei...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05359965
Start Date
October 1 2019
End Date
September 1 2025
Last Update
March 30 2025
Active Locations (1)
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1
University of Arizona
Tucson, Arizona, United States, 85724