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

University of Arizona

Status: Active, not recruiting

Conditions: Gastro Esophageal Reflux; Idiopathic Pulmonary Fibrosis; Obstructive Sleep Apnea

Treatments: Device: Positive Airway Pressure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05359965

IIS2018-10747

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

CPAP

Experimental group

Description:

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

Treatment:

Device: Positive Airway Pressure

No CPAP

No Intervention group

Description:

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