Effect of CPAP on Abnormal Gastroesophageal Reflux and Lung Inflammation in IPF

Last updated: March 27, 2025
Sponsor: University of Arizona
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cystic Fibrosis

Pneumonia

Scar Tissue

Treatment

Positive Airway Pressure

Clinical Study ID

NCT05359965
IIS2018-10747
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 enrollmentin 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 theprotocol

Exclusion

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 pHprobe placement

  • patients who were diagnosed with recent IPF exacerbation within 4 weeks ofenrollment (may be rescheduled for enrollment once recovered)

  • patients who have had prior nasal surgery or trauma that would make pH probeplacement difficult

  • patients on anticoagulation (aspirin is not an exclusion)

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Positive Airway Pressure
Phase:
Study Start date:
October 01, 2019
Estimated Completion Date:
September 01, 2025

Study 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.

Connect with a study center

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Site Not Available

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