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Positive Airway Pressure
CPAP for Idiopathic Pulmonary Fibrosis
N/A
Recruiting
Led By Sachin Chaudhary, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to comply with CPAP treatment
Confirmed diagnosis of IPF based on the 2018 IPF guidelines
Must not have
Patients who are unable to tolerate nintedanib
Interstitial lung disease caused by conditions other than IPF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether using CPAP to treat sleep apnea can improve symptoms in patients with idiopathic pulmonary fibrosis.
Who is the study for?
This trial is for people with idiopathic pulmonary fibrosis (IPF) and suspected sleep apnea, who can handle a CPAP machine and are on or starting nintedanib treatment. They must be able to undergo 24hr pH monitoring, provide consent, and follow the study plan. It's not for those with severe lung diseases other than IPF, recent nasal surgery, or life expectancy less than a year.
What is being tested?
The study tests if using a CPAP machine at night can help reduce acid reflux and lung inflammation in patients who have both IPF and sleep apnea. Participants will use CPAP therapy alongside their usual IPF treatment with nintedanib.
What are the potential side effects?
CPAP may cause discomfort like dry nose or throat, skin irritation from the mask, feeling of claustrophobia, sinus pain or pressure changes. These side effects vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can follow through with CPAP treatment.
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My condition is officially diagnosed as IPF according to 2018 guidelines.
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I am currently taking nintedanib or will start it before joining the study.
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I can undergo a 24-hour pH monitoring test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot tolerate nintedanib due to side effects.
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I have a lung condition not caused by IPF.
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I do not have a severe illness that limits my life expectancy to less than a year.
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I have had nasal surgery or an injury that could complicate pH probe placement.
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I cannot or do not want to use CPAP or undergo a 24-hour pH probe test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite Biomarker Score
Secondary study objectives
24hr-Esophageal pH
Biomarker of Lung Inflammation: CXCL13
Biomarker of Lung Inflammation: IL-8
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CPAPExperimental Treatment1 Intervention
Subjects randomized to the treatment arm, will receive continuous positive airway pressure (CPAP) while sleeping via an autoPAP device for 4-8 weeks.
Group II: No CPAPActive Control1 Intervention
Subjects assigned to the no CPAP group will not have any intervention for a 4-8 week period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positive Airway Pressure
2009
N/A
~490
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
539 Previous Clinical Trials
161,656 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,554 Previous Clinical Trials
15,897,275 Total Patients Enrolled
52 Trials studying Idiopathic Pulmonary Fibrosis
47,921 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Sachin Chaudhary, MDPrincipal InvestigatorUniversity of Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a recent worsening of my lung condition but have since recovered.I can follow through with CPAP treatment.My condition is officially diagnosed as IPF according to 2018 guidelines.You are likely to have obstructive sleep apnea based on the STOP-BANG measure, with a score of 3 or more.Your lung function test shows a specific ratio that indicates obstructive lung disease.I cannot tolerate nintedanib due to side effects.I am currently taking nintedanib or will start it before joining the study.You are currently addicted to drugs or alcohol.Your lung volume is more than 120% of what is expected.I have a lung condition not caused by IPF.I am taking blood thinners, but not aspirin.I do not have a severe illness that limits my life expectancy to less than a year.I can undergo a 24-hour pH monitoring test.I have had nasal surgery or an injury that could complicate pH probe placement.I cannot or do not want to use CPAP or undergo a 24-hour pH probe test.
Research Study Groups:
This trial has the following groups:- Group 1: CPAP
- Group 2: No CPAP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.