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

NCT ID: NCT05359965

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2025-09-01

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.

Conditions

Idiopathic Pulmonary Fibrosis; Obstructive Sleep Apnea; Gastro Esophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CPAP

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

Group Type: EXPERIMENTAL

Positive Airway Pressure

Intervention Type: DEVICE

Gentle and steady pressure (with or without supplemental oxygen) delivered to the airways of the lungs while subjects are sleeping.

No CPAP

Subjects assigned to the no CPAP group will not have any intervention for a 4-8 week period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Positive Airway Pressure

Gentle and steady pressure (with or without supplemental oxygen) delivered to the airways of the lungs while subjects are sleeping.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sachin Chaudhary, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Other Identifiers

IIS2018-10747

Identifier Type: -

Identifier Source: org_study_id