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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 50 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05359965
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Arizona
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Sachin Chaudhary, MD
Principal Investigator Affiliation University of Arizona
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Idiopathic Pulmonary Fibrosis, Obstructive Sleep Apnea, Gastro Esophageal Reflux
Additional Details

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.

Arms & Interventions

Arms

Experimental: CPAP

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

No Intervention: No CPAP

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

Interventions

Device: - Positive Airway Pressure

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Arizona, Tucson, Arizona

Status

Recruiting

Address

University of Arizona

Tucson, Arizona, 85724

Site Contact

Heidi Erickson, RN

herickso@email.arizona.edu

520-626-5287

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