Effect of CPAP on Abnormal Gastroesophageal Reflux and Lung Inflammation in IPF
Stopped early · Not applicable
Conditions studied: Idiopathic Pulmonary Fibrosis, Obstructive Sleep Apnea, Gastro Esophageal Reflux
In brief
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.
Key facts
- Study ID
- NCT05359965
- Run by
- University of Arizona
- People needed
- 7
- Starts
- 2019-10-01
- Expected to finish
- 2025-02-11
- Last updated by the study team
- 2026-03-09
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University of Arizona — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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