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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 more

Awards & 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
534 Previous Clinical Trials
159,455 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,549 Previous Clinical Trials
14,401,296 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

CPAP (Positive Airway Pressure) Clinical Trial Eligibility Overview. Trial Name: NCT05359965 — N/A
Idiopathic Pulmonary Fibrosis Research Study Groups: CPAP, No CPAP
Idiopathic Pulmonary Fibrosis Clinical Trial 2023: CPAP Highlights & Side Effects. Trial Name: NCT05359965 — N/A
CPAP (Positive Airway Pressure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05359965 — N/A
~0 spots leftby Dec 2024
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