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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite Biomarker Score
Secondary outcome measures
24hr-Esophageal pH
Biomarker of Lung Inflammation: CXCL13
Biomarker of Lung Inflammation: IL-8
+6 moreTrial 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
514 Previous Clinical Trials
148,574 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,507 Previous Clinical Trials
11,340,887 Total Patients Enrolled
49 Trials studying Idiopathic Pulmonary Fibrosis
45,361 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants can be accepted into this study?
"Indeed, the clinical trial is currently enrolling patients as per information hosted on clinicaltrials.gov. First posted in October 2019, the study was last updated on September 15th 2022 and seeks to enrol 20 individuals at a single site."
Answered by AI
Is the patient population for this research still being accepted?
"This trial is still actively searching for participants, as confirmed by the clinicaltrials.gov website. The initial posting date was October 1st 2019 and it was last updated around September 15th 2022."
Answered by AI
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