Effect of Continuous Positive Airway Pressure (CPAP) on Abnormal Gastroesophageal Reflux and Lung Inflammation in Idiopathic Pulmonary Fibrosis (IPF)

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    20
  • sponsor
    University of Arizona
Updated on 13 October 2022
nintedanib
idiopathic pulmonary fibrosis

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.

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.

Details
Condition Idiopathic Pulmonary Fibrosis, Obstructive Sleep Apnea, Gastro Esophageal Reflux
Treatment Positive Airway Pressure
Clinical Study IdentifierNCT05359965
SponsorUniversity of Arizona
Last Modified on13 October 2022

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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