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

Not Applicable

Active, not recruiting

• Conditions: Obstructive Sleep Apnea; Idiopathic Pulmonary Fibrosis; Gastro Esophageal Reflux
• Interventions: Device: Positive Airway Pressure

• Registration Number: NCT05359965
• Lead Sponsor: University of Arizona

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 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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-07
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP	Positive Airway Pressure	Subjects randomized to the treatment arm, will receive continuous positive airway pressure (CPAP) while sleeping via an autoPAP device for 4-8 weeks.

Primary Outcome Measures

Name	Time	Method
Composite Biomarker Score	4-8 weeks	The primary outcome will be a composite value that is a weighted average of z-scores of the biomarkers MMP1, MMP7, IL-8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker. MMP1, MMP7, IL-8, KL-6, and CXCL13 will be measured using enzyme linked immunosorbent assays (ELISA) for these analytes. (Z-score is a unitless number, as is the weighted average.)

Secondary Outcome Measures

Name	Time	Method
Biomarker of Lung Inflammation: KL-6	4-8 weeks	The value of KL-6 measured by ELISA in U/ml.
Biomarker of Lung Inflammation: MMP1	4-8 weeks	The value of MMP1 measured by ELISA in ng/ml.
Esophageal pH During Sleep	4-8 weeks	Total sleep time (in minutes) with pH less than 4.
Composite Biomarker Score at Six Months	6 months	Weighted average of z-scores of the biomarkers MMP1, MMP7, IL8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker at six months. (Z-score is a unitless number, as is the weighted average.)
Biomarker of Lung Inflammation: IL-8	4-8 weeks	The value of IL-8 measured by ELISA in pg/ml.
FVC change	6 months	FVC change in percentage of predicted values over 6 months (baseline to 6 months).
Biomarker of Lung Inflammation: MMP7	4-8 weeks	The value of MMP7 measured by ELISA in ng/ml.
Biomarker of Lung Inflammation: CXCL13	4-8 weeks	The value of CXCL-13 measured by ELISA in pg/ml.
24hr-Esophageal pH	4-8 weeks	Total time (minutes in 24hr period) with pH less than 4.

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States